Trial Outcomes & Findings for A Phase Ib/II Study of LGX818 in Combination With MEK162 in Adult Patients With BRAF Dependent Advanced Solid Tumors (NCT NCT01543698)
NCT ID: NCT01543698
Last Updated: 2024-03-13
Results Overview
DLT was defined as an adverse event or abnormal laboratory value assessed as at least possibly related to the study medication, as clinically relevant, as unrelated to disease, disease progression, inter-current illness, or concomitant medications, which occurred (less than equal to) \<=28 days following the first dose of LGX818 and MEK162 or LGX818 and MEK162 and LEE011 (cycle 1) and met the defined criteria for the study.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
189 participants
Primary outcome timeframe
Phase 1b: Cycle 1 (28 days following the first dose of LGX818 and MEK162 or LGX818 and MEK162 and LEE011)
Results posted on
2024-03-13
Participant Flow
This study had 2 Phases- 1b and 2. Phase 1b enrolled participants with V-raf murine sarcoma viral oncogene homolog B1 (BRAF) V600-dependent advanced solid tumors. Phase 2 enrolled participants with: BRAF V600 mutant metastatic colorectal cancer (mCRC) \[Arm 1, dual\]; BRAF V600 mutant melanoma who progressed after prior selective BRAF inhibitor treatment \[Arm 2, dual\]; metastatic BRAF mutant melanoma who were naïve to prior treatment with a selective BRAF inhibitor \[Arm 3, dual\]/ \[Arm A, triple\].
A total of 189 participants were enrolled. Phase 1 b: 47 participants for dual combination and 21 participants for triple combination. Phase 2: a) Dual combination- Arm 1 (mCRC) =11 participants; Arm 2 (prior BRAFi melanoma) =26 participants; Arm 3 (BRAFi-naïve melanoma) =42 participants and b) Triple combination- Arm A (BRAFi-naïve melanoma) =42 participants. Dual combination of LGX818 (encorafenib) and MEK162 (binimetinib) and triple combination of LGX818, MEK162 and LEE011 (ribociclib).
Participant milestones
| Measure |
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
Participants received Encorafenib 50 milligram (mg) once daily (QD) and Binimetinib 45 mg twice a daily (BID) orally 4 weeks till sponsor/investigator determined the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D), until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
|
Phase 1b: Encorafenib 100 mg+ Binimetinib 45 mg
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally for 4 weeks till sponsor/investigator determined MTD and/or RP2D, until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally for 4 weeks till sponsor/investigator determined MTD and/or RP2D, until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
|
Phase 1b: Encorafenib 400 mg + Binimetinib 45 mg
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally for 4 weeks till sponsor/investigator determined MTD and/or RP2D, until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
|
Phase 1b: Encorafenib 450 mg+ Binimetinib 45 mg
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally for 4 weeks till sponsor/investigator determined MTD and/or RP2D, until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
|
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally for 4 weeks till sponsor/investigator determined MTD and/or RP2D, until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
|
Phase 1b: Encorafenib 800 mg + Binimetinib 45 mg
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally for 4 weeks till sponsor/investigator determined MTD and/or RP2D, until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 100 mg
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks, and Ribociclib 100 mg BID orally for 3 weeks on, 1 week off schedule, till sponsor/investigator determined MTD and/or RP2D, until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 200 mg
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks, and Ribociclib 200 mg BID orally for 3 weeks on, 1 week off schedule, till sponsor/investigator determined MTD and/or RP2D, until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 400 mg
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks, and Ribociclib 400 mg BID orally for 3 weeks on, 1 week off schedule, till sponsor/investigator determined MTD and/or RP2D, until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg + Ribociclib 600 mg
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks, and Ribociclib 600 mg BID orally for 3 weeks on, 1 week off schedule, till sponsor/investigator determined MTD and/or RP2D, until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
|
Phase 2: Arm 1 (mCRC): Encorafenib + Binimetinib
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
|
Phase 2: Arm 2 (Prior BRAFi Melanoma): Encorafenib + Binimetinib
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
|
Phase 2: Arm 3 (BRAFi-naïve Melanoma): Encorafenib + Binimetinib
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
|
Phase 2: Arm A (BRAFi-naïve Melanoma): Encorafenib + Binimetinib + Ribociclib
Participants received Encorafenib 200 mg QD (MTD), Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks, and Ribociclib 600 mg QD orally for 3 weeks on, 1 week off schedule until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b
STARTED
|
6
|
5
|
4
|
5
|
13
|
8
|
6
|
4
|
5
|
6
|
6
|
0
|
0
|
0
|
0
|
|
Phase 1b
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1b
NOT COMPLETED
|
6
|
5
|
4
|
5
|
13
|
8
|
6
|
4
|
5
|
6
|
6
|
0
|
0
|
0
|
0
|
|
Phase 2
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
11
|
26
|
42
|
42
|
|
Phase 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
11
|
26
|
42
|
42
|
Reasons for withdrawal
| Measure |
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
Participants received Encorafenib 50 milligram (mg) once daily (QD) and Binimetinib 45 mg twice a daily (BID) orally 4 weeks till sponsor/investigator determined the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D), until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
|
Phase 1b: Encorafenib 100 mg+ Binimetinib 45 mg
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally for 4 weeks till sponsor/investigator determined MTD and/or RP2D, until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally for 4 weeks till sponsor/investigator determined MTD and/or RP2D, until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
|
Phase 1b: Encorafenib 400 mg + Binimetinib 45 mg
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally for 4 weeks till sponsor/investigator determined MTD and/or RP2D, until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
|
Phase 1b: Encorafenib 450 mg+ Binimetinib 45 mg
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally for 4 weeks till sponsor/investigator determined MTD and/or RP2D, until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
|
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally for 4 weeks till sponsor/investigator determined MTD and/or RP2D, until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
|
Phase 1b: Encorafenib 800 mg + Binimetinib 45 mg
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally for 4 weeks till sponsor/investigator determined MTD and/or RP2D, until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 100 mg
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks, and Ribociclib 100 mg BID orally for 3 weeks on, 1 week off schedule, till sponsor/investigator determined MTD and/or RP2D, until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 200 mg
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks, and Ribociclib 200 mg BID orally for 3 weeks on, 1 week off schedule, till sponsor/investigator determined MTD and/or RP2D, until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 400 mg
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks, and Ribociclib 400 mg BID orally for 3 weeks on, 1 week off schedule, till sponsor/investigator determined MTD and/or RP2D, until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg + Ribociclib 600 mg
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks, and Ribociclib 600 mg BID orally for 3 weeks on, 1 week off schedule, till sponsor/investigator determined MTD and/or RP2D, until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
|
Phase 2: Arm 1 (mCRC): Encorafenib + Binimetinib
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
|
Phase 2: Arm 2 (Prior BRAFi Melanoma): Encorafenib + Binimetinib
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
|
Phase 2: Arm 3 (BRAFi-naïve Melanoma): Encorafenib + Binimetinib
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
|
Phase 2: Arm A (BRAFi-naïve Melanoma): Encorafenib + Binimetinib + Ribociclib
Participants received Encorafenib 200 mg QD (MTD), Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks, and Ribociclib 600 mg QD orally for 3 weeks on, 1 week off schedule until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b
Disease progression
|
2
|
4
|
3
|
2
|
10
|
6
|
5
|
3
|
4
|
5
|
1
|
0
|
0
|
0
|
0
|
|
Phase 1b
Death
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Phase 1b
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1b
Adverse Event
|
1
|
0
|
0
|
1
|
2
|
2
|
0
|
0
|
1
|
1
|
2
|
0
|
0
|
0
|
0
|
|
Phase 1b
Administrative problems
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Phase 1b
Protocol Violation
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Phase 2
Disease progression
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
10
|
21
|
30
|
25
|
|
Phase 2
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
|
Phase 2
Administrative problems
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
1
|
|
Phase 2
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
1
|
|
Phase 2
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
3
|
5
|
14
|
Baseline Characteristics
A Phase Ib/II Study of LGX818 in Combination With MEK162 in Adult Patients With BRAF Dependent Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
n=6 Participants
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 100 mg+ Binimetinib 45 mg
n=5 Participants
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
n=4 Participants
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 400 mg + Binimetinib 45 mg
n=5 Participants
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 450 mg+ Binimetinib 45 mg
n=13 Participants
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
n=8 Participants
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 800 mg + Binimetinib 45 mg
n=6 Participants
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 100 mg
n=4 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on, 1 week off schedule.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 200 mg
n=5 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on, 1 week off schedule.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 400 mg
n=6 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on, 1 week off schedule.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg + Ribociclib 600 mg
n=6 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on, 1 week off schedule.
|
Phase 2: Arm 1 (mCRC): Encorafenib + Binimetinib
n=11 Participants
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
|
Phase 2: Arm 2 (Prior BRAFi Melanoma): Encorafenib + Binimetinib
n=26 Participants
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks.
|
Phase 2: Arm 3 (BRAFi-naïve Melanoma): Encorafenib + Binimetinib
n=42 Participants
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks.
|
Phase 2: Arm A (BRAFi-naïve Melanoma): Encorafenib + Binimetinib + Ribociclib
n=42 Participants
Participants received Encorafenib 200 mg QD (MTD), Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks, and Ribociclib 600 mg QD orally for 3 weeks on, 1 week off schedule.
|
Total
n=189 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=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
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
22 Participants
n=36 Participants
|
33 Participants
n=36 Participants
|
32 Participants
n=24 Participants
|
149 Participants
n=135 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
4 Participants
n=36 Participants
|
9 Participants
n=36 Participants
|
10 Participants
n=24 Participants
|
40 Participants
n=135 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
11 Participants
n=36 Participants
|
12 Participants
n=36 Participants
|
19 Participants
n=24 Participants
|
77 Participants
n=135 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
15 Participants
n=36 Participants
|
30 Participants
n=36 Participants
|
23 Participants
n=24 Participants
|
112 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
24 Participants
n=36 Participants
|
37 Participants
n=36 Participants
|
42 Participants
n=24 Participants
|
177 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
6 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
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
|
1 Participants
n=36 Participants
|
5 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
6 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic/Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
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
|
2 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
4 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Chinese
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
5 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
24 Participants
n=36 Participants
|
41 Participants
n=36 Participants
|
41 Participants
n=24 Participants
|
180 Participants
n=135 Participants
|
PRIMARY outcome
Timeframe: Phase 1b: Cycle 1 (28 days following the first dose of LGX818 and MEK162 or LGX818 and MEK162 and LEE011)Population: Dose Determining Set (DDS) included all Phase 1b participants from the safety set who either completed a minimum exposure requirement and had sufficient safety evaluations or discontinued prematurely due to a DLT. All participants reported under "Number of Participants Analyzed" contributed data to this outcome measure.
DLT was defined as an adverse event or abnormal laboratory value assessed as at least possibly related to the study medication, as clinically relevant, as unrelated to disease, disease progression, inter-current illness, or concomitant medications, which occurred (less than equal to) \<=28 days following the first dose of LGX818 and MEK162 or LGX818 and MEK162 and LEE011 (cycle 1) and met the defined criteria for the study.
Outcome measures
| Measure |
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
n=6 Participants
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 100 mg + Binimetinib 45 mg
n=5 Participants
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
n=2 Participants
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 400 mg + Binimetinib 45 mg
n=4 Participants
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 450 mg + Binimetinib 45 mg
n=13 Participants
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
n=8 Participants
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 800 mg + Binimetinib 45 mg
n=6 Participants
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 100 mg
n=4 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg + Ribociclib 200 mg
n=5 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 400 mg
n=5 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 600 mg
n=5 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs): Phase 1b
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Phase 2: Week 16Population: Full Analysis Set (FAS) included all participants who received at least one dose of LGX818 or MEK162 or LEE011.
DCR was defined as percentage of participants with a best overall response of complete response (CR), partial response (PR) or stable disease (SD). As per Response Evaluation Criteria in Solid tumors Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must have a reduction in short axis less than (\<)10 millimeter \[mm\]). PR was defined as more than equal to (\>=) 30 percent (%) decrease under baseline of sum of diameters of all target lesions taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease (PD).
Outcome measures
| Measure |
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
n=11 Participants
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 100 mg + Binimetinib 45 mg
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 400 mg + Binimetinib 45 mg
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 450 mg + Binimetinib 45 mg
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 800 mg + Binimetinib 45 mg
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 100 mg
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg + Ribociclib 200 mg
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 400 mg
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 600 mg
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Disease Control Rate (DCR) at Week 16: Phase 2, Arm 1 (mCRC Participants)
|
63.6 Percentage of participants
Interval 30.8 to 89.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Phase 2: From Day 1 of dosing till complete response or partial response achieved (maximum exposure of treatment for Phase 2 was 111.5 months]Population: FAS included all participants who received at least one dose of LGX818 or MEK162 or LEE011.
ORR was defined as the percentage of participants with a best overall response of CR or PR. As per RECIST v1.1, CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must have a reduction in short axis \<10 mm. PR was defined as \>= 30% decrease under baseline of sum of diameters of all target lesions taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
n=26 Participants
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 100 mg + Binimetinib 45 mg
n=42 Participants
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
n=42 Participants
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 400 mg + Binimetinib 45 mg
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 450 mg + Binimetinib 45 mg
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 800 mg + Binimetinib 45 mg
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 100 mg
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg + Ribociclib 200 mg
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 400 mg
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 600 mg
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR): Phase 2, Arms 2, 3 and A
|
42.3 Percentage of participants
Interval 23.4 to 63.1
|
66.7 Percentage of participants
Interval 50.5 to 80.4
|
59.5 Percentage of participants
Interval 43.3 to 74.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Phase 1b: Day 1 up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months)Population: Safety set included all participants who received at least one dose of LGX818 or MEK162 or LEE011 and had at least one valid post-baseline safety assessment.
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were those events with onset dates occurring during the on-treatment period (the time from the Day 1 up to 30 days after last dose). AEs were graded according to National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 as Grade 1 indicates Mild AE, Grade 2 indicates Moderate AE, Grade 3 indicates severe AE, and grade 4 indicates life-threatening consequences; urgent intervention indicated. Grade 5 indicates death related to AE.
Outcome measures
| Measure |
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
n=6 Participants
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 100 mg + Binimetinib 45 mg
n=5 Participants
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
n=4 Participants
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 400 mg + Binimetinib 45 mg
n=5 Participants
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 450 mg + Binimetinib 45 mg
n=13 Participants
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
n=8 Participants
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 800 mg + Binimetinib 45 mg
n=6 Participants
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 100 mg
n=4 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg + Ribociclib 200 mg
n=5 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 400 mg
n=6 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 600 mg
n=6 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs): Overall Grades and AEs of Grade 3/4: Phase 1b
Overall Grades
|
6 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
13 Participants
|
8 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs): Overall Grades and AEs of Grade 3/4: Phase 1b
Grade 3/4
|
5 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
8 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Phase 2: Day 1 up to 30 days after last dose (maximum treatment exposure for Phase 2 was 111.5 months)Population: Safety set included all participants who received at least one dose of LGX818 or MEK162 or LEE011 and had at least one valid post-baseline safety assessment.
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were those events with onset dates occurring during the on-treatment period (the time from the Day 1 up to 30 days after last dose). AEs were graded according to CTCAE version 4.03 as Grade 1 indicates Mild AE, Grade 2 indicates Moderate AE, Grade 3 indicates severe AE, and grade 4 indicates life-threatening consequences; urgent intervention indicated. Grade 5 indicates death related to AE.
Outcome measures
| Measure |
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
n=11 Participants
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 100 mg + Binimetinib 45 mg
n=26 Participants
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
n=42 Participants
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 400 mg + Binimetinib 45 mg
n=42 Participants
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 450 mg + Binimetinib 45 mg
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 800 mg + Binimetinib 45 mg
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 100 mg
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg + Ribociclib 200 mg
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 400 mg
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 600 mg
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs: Overall Grades and AEs of Grade 3/4: Phase 2
Overall Grades
|
11 Participants
|
26 Participants
|
42 Participants
|
42 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs: Overall Grades and AEs of Grade 3/4: Phase 2
Grade 3/4
|
5 Participants
|
15 Participants
|
27 Participants
|
34 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Phase 1b: Pre dose, 0.5,1.5,2.5,4,6,8 and 24 hours (hr) post dose on Day 1 of Cycle 1Population: FAS evaluated. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
AUCinf was reported in unit of measure as hour\*nanogram per millilitre (h\*ng/mL).
Outcome measures
| Measure |
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
n=6 Participants
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 100 mg + Binimetinib 45 mg
n=5 Participants
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
n=4 Participants
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 400 mg + Binimetinib 45 mg
n=5 Participants
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 450 mg + Binimetinib 45 mg
n=13 Participants
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
n=8 Participants
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 800 mg + Binimetinib 45 mg
n=6 Participants
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 100 mg
n=4 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg + Ribociclib 200 mg
n=5 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 400 mg
n=6 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 600 mg
n=6 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to Infinity With Extrapolation of the Terminal Phase (AUCinf) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Encorafenib
|
3740 h*ng/mL
Standard Deviation 2350
|
11700 h*ng/mL
Standard Deviation 6200
|
22000 h*ng/mL
Standard Deviation 9790
|
42000 h*ng/mL
Standard Deviation 23600
|
36700 h*ng/mL
Standard Deviation 19400
|
57400 h*ng/mL
Standard Deviation 27100
|
40200 h*ng/mL
Standard Deviation 12100
|
15000 h*ng/mL
Standard Deviation 7360
|
9960 h*ng/mL
Standard Deviation 5940
|
18900 h*ng/mL
Standard Deviation 9900
|
17400 h*ng/mL
Standard Deviation 9480
|
|
Area Under the Concentration-time Curve From Time Zero to Infinity With Extrapolation of the Terminal Phase (AUCinf) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Binimetinib
|
2190 h*ng/mL
Standard Deviation 1350
|
1930 h*ng/mL
Standard Deviation 529
|
3730 h*ng/mL
Standard Deviation 2250
|
1960 h*ng/mL
Standard Deviation 1140
|
2750 h*ng/mL
Standard Deviation 1490
|
3090 h*ng/mL
Standard Deviation 1600
|
2340 h*ng/mL
Standard Deviation 462
|
2160 h*ng/mL
Standard Deviation 1580
|
3000 h*ng/mL
Standard Deviation 932
|
3110 h*ng/mL
Standard Deviation 1450
|
2970 h*ng/mL
Standard Deviation 458
|
|
Area Under the Concentration-time Curve From Time Zero to Infinity With Extrapolation of the Terminal Phase (AUCinf) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Ribociclib
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1040 h*ng/mL
Standard Deviation 665
|
3030 h*ng/mL
Standard Deviation 1600
|
7930 h*ng/mL
Standard Deviation 5180
|
18200 h*ng/mL
Standard Deviation 10400
|
|
Area Under the Concentration-time Curve From Time Zero to Infinity With Extrapolation of the Terminal Phase (AUCinf) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Metabolite of Binimetinib
|
321 h*ng/mL
Standard Deviation 225
|
271 h*ng/mL
Standard Deviation 28.9
|
631 h*ng/mL
Standard Deviation 296
|
275 h*ng/mL
Standard Deviation 121
|
361 h*ng/mL
Standard Deviation 184
|
449 h*ng/mL
Standard Deviation 302
|
361 h*ng/mL
Standard Deviation 78.1
|
173 h*ng/mL
Standard Deviation 55.6
|
337 h*ng/mL
Standard Deviation 29.2
|
—
|
239 h*ng/mL
Standard Deviation 79.1
|
|
Area Under the Concentration-time Curve From Time Zero to Infinity With Extrapolation of the Terminal Phase (AUCinf) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Metabolite of Ribociclib
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
194 h*ng/mL
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was evaluable.
|
601 h*ng/mL
Standard Deviation 225
|
1340 h*ng/mL
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was evaluable.
|
2160 h*ng/mL
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was evaluable.
|
SECONDARY outcome
Timeframe: Phase 1b: Pre dose, 0.5,1.5,2.5,4,6,8 and 24 hr post dose on Day 1 of Cycle 1Population: FAS evaluated. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
Outcome measures
| Measure |
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
n=6 Participants
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 100 mg + Binimetinib 45 mg
n=5 Participants
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
n=4 Participants
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 400 mg + Binimetinib 45 mg
n=5 Participants
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 450 mg + Binimetinib 45 mg
n=13 Participants
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
n=8 Participants
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 800 mg + Binimetinib 45 mg
n=6 Participants
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 100 mg
n=4 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg + Ribociclib 200 mg
n=5 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 400 mg
n=6 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 600 mg
n=6 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Encorafenib
|
3690 h*ng/mL
Standard Deviation 2340
|
11500 h*ng/mL
Standard Deviation 6070
|
22000 h*ng/mL
Standard Deviation 9750
|
40200 h*ng/mL
Standard Deviation 21700
|
36100 h*ng/mL
Standard Deviation 19300
|
57000 h*ng/mL
Standard Deviation 26800
|
38100 h*ng/mL
Standard Deviation 11800
|
11400 h*ng/mL
Standard Deviation 4530
|
9280 h*ng/mL
Standard Deviation 4190
|
12700 h*ng/mL
Standard Deviation 5020
|
15800 h*ng/mL
Standard Deviation 7160
|
|
Area Under the Concentration-Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Binimetinib
|
1990 h*ng/mL
Standard Deviation 1130
|
1990 h*ng/mL
Standard Deviation 715
|
3300 h*ng/mL
Standard Deviation 1990
|
1870 h*ng/mL
Standard Deviation 867
|
2330 h*ng/mL
Standard Deviation 1220
|
2790 h*ng/mL
Standard Deviation 1480
|
2120 h*ng/mL
Standard Deviation 478
|
1520 h*ng/mL
Standard Deviation 663
|
2470 h*ng/mL
Standard Deviation 878
|
2020 h*ng/mL
Standard Deviation 843
|
2320 h*ng/mL
Standard Deviation 635
|
|
Area Under the Concentration-Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Ribociclib
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
806 h*ng/mL
Standard Deviation 549
|
2550 h*ng/mL
Standard Deviation 1280
|
6700 h*ng/mL
Standard Deviation 3720
|
14500 h*ng/mL
Standard Deviation 7490
|
|
Area Under the Concentration-Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Metabolite of Binimetinib
|
276 h*ng/mL
Standard Deviation 184
|
280 h*ng/mL
Standard Deviation 50.5
|
372 h*ng/mL
Standard Deviation 320
|
241 h*ng/mL
Standard Deviation 82.5
|
287 h*ng/mL
Standard Deviation 122
|
340 h*ng/mL
Standard Deviation 244
|
307 h*ng/mL
Standard Deviation 78.4
|
156 h*ng/mL
Standard Deviation 53.8
|
259 h*ng/mL
Standard Deviation 54.3
|
168 h*ng/mL
Standard Deviation 109
|
161 h*ng/mL
Standard Deviation 81.9
|
|
Area Under the Concentration-Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Metabolite of Ribociclib
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
81.4 h*ng/mL
Standard Deviation 41.0
|
397 h*ng/mL
Standard Deviation 145
|
758 h*ng/mL
Standard Deviation 231
|
1200 h*ng/mL
Standard Deviation 320
|
SECONDARY outcome
Timeframe: Phase 1b: Pre dose,0.5,1.5, 2.5,4,6,8 and 24 hr post dose on Day 15 of Cycle 1Population: FAS evaluated. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
Outcome measures
| Measure |
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
n=6 Participants
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 100 mg + Binimetinib 45 mg
n=5 Participants
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
n=4 Participants
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 400 mg + Binimetinib 45 mg
n=5 Participants
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 450 mg + Binimetinib 45 mg
n=13 Participants
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
n=8 Participants
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 800 mg + Binimetinib 45 mg
n=6 Participants
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 100 mg
n=4 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg + Ribociclib 200 mg
n=5 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 400 mg
n=6 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 600 mg
n=6 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUClast at Steady State (AUClast,ss) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Encorafenib
|
2620 h*ng/mL
Standard Deviation 1260
|
5510 h*ng/mL
Standard Deviation 1280
|
4620 h*ng/mL
Standard Deviation 1640
|
10200 h*ng/mL
Standard Deviation 2280
|
15900 h*ng/mL
Standard Deviation 8730
|
27300 h*ng/mL
Standard Deviation 17900
|
25300 h*ng/mL
Standard Deviation 7240
|
6310 h*ng/mL
Standard Deviation 2340
|
8210 h*ng/mL
Standard Deviation 2550
|
11800 h*ng/mL
Standard Deviation 7000
|
15700 h*ng/mL
Standard Deviation 6060
|
|
AUClast at Steady State (AUClast,ss) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Binimetinib
|
2950 h*ng/mL
Standard Deviation 1380
|
2610 h*ng/mL
Standard Deviation 873
|
2660 h*ng/mL
Standard Deviation 1900
|
2110 h*ng/mL
Standard Deviation 1220
|
2550 h*ng/mL
Standard Deviation 901
|
2590 h*ng/mL
Standard Deviation 1640
|
2540 h*ng/mL
Standard Deviation 529
|
2180 h*ng/mL
Standard Deviation 1180
|
2820 h*ng/mL
Standard Deviation 954
|
2740 h*ng/mL
Standard Deviation 1230
|
2970 h*ng/mL
Standard Deviation 1180
|
|
AUClast at Steady State (AUClast,ss) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Ribociclib
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
462 h*ng/mL
Standard Deviation 129
|
1520 h*ng/mL
Standard Deviation 979
|
5620 h*ng/mL
Standard Deviation 3730
|
10100 h*ng/mL
Standard Deviation 2970
|
|
AUClast at Steady State (AUClast,ss) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Metabolite of Binimetinib
|
147 h*ng/mL
Standard Deviation 152
|
173 h*ng/mL
Standard Deviation 125
|
118 h*ng/mL
Standard Deviation 70.7
|
119 h*ng/mL
Standard Deviation 96.5
|
157 h*ng/mL
Standard Deviation 104
|
132 h*ng/mL
Standard Deviation 142
|
190 h*ng/mL
Standard Deviation 79.8
|
149 h*ng/mL
Standard Deviation 136
|
210 h*ng/mL
Standard Deviation 68.4
|
176 h*ng/mL
Standard Deviation 92.5
|
169 h*ng/mL
Standard Deviation 48.5
|
|
AUClast at Steady State (AUClast,ss) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Metabolite of Ribociclib
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
255 h*ng/mL
Standard Deviation 131
|
729 h*ng/mL
Standard Deviation 267
|
2150 h*ng/mL
Standard Deviation 399
|
3260 h*ng/mL
Standard Deviation 891
|
SECONDARY outcome
Timeframe: Phase 1b: Pre dose, 0.5,1.5,2.5,4,6,8 and 24 hr post dose on Day 1 of Cycle 1Population: FAS evaluated. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
Outcome measures
| Measure |
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
n=6 Participants
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 100 mg + Binimetinib 45 mg
n=5 Participants
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
n=4 Participants
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 400 mg + Binimetinib 45 mg
n=5 Participants
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 450 mg + Binimetinib 45 mg
n=13 Participants
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
n=8 Participants
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 800 mg + Binimetinib 45 mg
n=6 Participants
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 100 mg
n=4 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg + Ribociclib 200 mg
n=5 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 400 mg
n=6 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 600 mg
n=6 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From Time Zero to Tau After First Dose (AUCtau) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Encorafenib
|
3700 h*ng/mL
Standard Deviation 2320
|
11500 h*ng/mL
Standard Deviation 6070
|
22000 h*ng/mL
Standard Deviation 9750
|
40200 h*ng/mL
Standard Deviation 21700
|
36300 h*ng/mL
Standard Deviation 19000
|
57000 h*ng/mL
Standard Deviation 26800
|
40000 h*ng/mL
Standard Deviation 12100
|
14800 h*ng/mL
Standard Deviation 7140
|
9940 h*ng/mL
Standard Deviation 5900
|
18700 h*ng/mL
Standard Deviation 9730
|
17300 h*ng/mL
Standard Deviation 9300
|
|
Area Under the Concentration-Time Curve From Time Zero to Tau After First Dose (AUCtau) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Binimetinib
|
2130 h*ng/mL
Standard Deviation 1330
|
1860 h*ng/mL
Standard Deviation 532
|
3600 h*ng/mL
Standard Deviation 2160
|
1890 h*ng/mL
Standard Deviation 1110
|
2650 h*ng/mL
Standard Deviation 1410
|
3010 h*ng/mL
Standard Deviation 1560
|
2280 h*ng/mL
Standard Deviation 477
|
1790 h*ng/mL
Standard Deviation 979
|
2900 h*ng/mL
Standard Deviation 939
|
2860 h*ng/mL
Standard Deviation 1320
|
2900 h*ng/mL
Standard Deviation 453
|
|
Area Under the Concentration-Time Curve From Time Zero to Tau After First Dose (AUCtau) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Ribociclib
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
845 h*ng/mL
Standard Deviation 504
|
2550 h*ng/mL
Standard Deviation 1280
|
6700 h*ng/mL
Standard Deviation 3720
|
14500 h*ng/mL
Standard Deviation 7490
|
|
Area Under the Concentration-Time Curve From Time Zero to Tau After First Dose (AUCtau) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Metabolite of Binimetinib
|
307 h*ng/mL
Standard Deviation 222
|
265 h*ng/mL
Standard Deviation 27.9
|
585 h*ng/mL
Standard Deviation 304
|
257 h*ng/mL
Standard Deviation 109
|
338 h*ng/mL
Standard Deviation 162
|
430 h*ng/mL
Standard Deviation 291
|
344 h*ng/mL
Standard Deviation 82.0
|
152 h*ng/mL
Standard Deviation 32.3
|
322 h*ng/mL
Standard Deviation 23.5
|
—
|
230 h*ng/mL
Standard Deviation 79.1
|
|
Area Under the Concentration-Time Curve From Time Zero to Tau After First Dose (AUCtau) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Metabolite of Ribociclib
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
98.9 h*ng/mL
Standard Deviation 25.9
|
397 h*ng/mL
Standard Deviation 145
|
758 h*ng/mL
Standard Deviation 231
|
1200 h*ng/mL
Standard Deviation 320
|
SECONDARY outcome
Timeframe: Phase 1b: Pre dose,0.5,1.5, 2.5,4,6,8 and 24 hr post dose on Day 15 of Cycle 1Population: FAS evaluated. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
Outcome measures
| Measure |
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
n=6 Participants
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 100 mg + Binimetinib 45 mg
n=5 Participants
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
n=4 Participants
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 400 mg + Binimetinib 45 mg
n=5 Participants
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 450 mg + Binimetinib 45 mg
n=13 Participants
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
n=8 Participants
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 800 mg + Binimetinib 45 mg
n=6 Participants
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 100 mg
n=4 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg + Ribociclib 200 mg
n=5 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 400 mg
n=6 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 600 mg
n=6 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUCtau at Steady State (AUCtau,ss) of Encorafenib, Binimetinib and Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Encorafenib
|
2620 h*ng/mL
Standard Deviation 1260
|
5510 h*ng/mL
Standard Deviation 1280
|
4620 h*ng/mL
Standard Deviation 1640
|
10200 h*ng/mL
Standard Deviation 2280
|
15900 h*ng/mL
Standard Deviation 8730
|
27300 h*ng/mL
Standard Deviation 17900
|
25300 h*ng/mL
Standard Deviation 7240
|
6310 h*ng/mL
Standard Deviation 2340
|
8210 h*ng/mL
Standard Deviation 2550
|
11800 h*ng/mL
Standard Deviation 7000
|
15700 h*ng/mL
Standard Deviation 6060
|
|
AUCtau at Steady State (AUCtau,ss) of Encorafenib, Binimetinib and Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Binimetinib
|
2950 h*ng/mL
Standard Deviation 1380
|
2610 h*ng/mL
Standard Deviation 873
|
2660 h*ng/mL
Standard Deviation 1900
|
2110 h*ng/mL
Standard Deviation 1220
|
2550 h*ng/mL
Standard Deviation 901
|
2590 h*ng/mL
Standard Deviation 1640
|
2540 h*ng/mL
Standard Deviation 529
|
2180 h*ng/mL
Standard Deviation 1180
|
2820 h*ng/mL
Standard Deviation 954
|
2740 h*ng/mL
Standard Deviation 1230
|
2970 h*ng/mL
Standard Deviation 1180
|
|
AUCtau at Steady State (AUCtau,ss) of Encorafenib, Binimetinib and Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Ribociclib
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
462 h*ng/mL
Standard Deviation 129
|
1520 h*ng/mL
Standard Deviation 979
|
5620 h*ng/mL
Standard Deviation 3730
|
10100 h*ng/mL
Standard Deviation 2970
|
|
AUCtau at Steady State (AUCtau,ss) of Encorafenib, Binimetinib and Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Metabolite of Binimetinib
|
261 h*ng/mL
Standard Deviation 136
|
237 h*ng/mL
Standard Deviation 107
|
126 h*ng/mL
Standard Deviation 59.5
|
194 h*ng/mL
Standard Deviation 75.8
|
221 h*ng/mL
Standard Deviation 83.5
|
304 h*ng/mL
Standard Deviation 77.7
|
225 h*ng/mL
Standard Deviation 25.1
|
265 h*ng/mL
Standard Deviation 33.4
|
219 h*ng/mL
Standard Deviation 71.5
|
207 h*ng/mL
Standard Deviation 69.7
|
175 h*ng/mL
Standard Deviation 52.8
|
|
AUCtau at Steady State (AUCtau,ss) of Encorafenib, Binimetinib and Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Metabolite of Ribociclib
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
255 h*ng/mL
Standard Deviation 131
|
729 h*ng/mL
Standard Deviation 267
|
2150 h*ng/mL
Standard Deviation 399
|
3260 h*ng/mL
Standard Deviation 891
|
SECONDARY outcome
Timeframe: Phase 1b: Pre dose, 0.5,1.5,2.5,4,6,8 and 24 hr post dose on Day 1 of Cycle 1Population: FAS evaluated. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
Outcome measures
| Measure |
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
n=6 Participants
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 100 mg + Binimetinib 45 mg
n=5 Participants
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
n=4 Participants
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 400 mg + Binimetinib 45 mg
n=5 Participants
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 450 mg + Binimetinib 45 mg
n=13 Participants
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
n=8 Participants
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 800 mg + Binimetinib 45 mg
n=6 Participants
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 100 mg
n=4 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg + Ribociclib 200 mg
n=5 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 400 mg
n=6 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 600 mg
n=6 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Encorafenib, Binimetinib, Ribociclib Metabolite of Binimetinib and Ribociclib: Phase 1b
Encorafenib
|
855 ng/mL
Standard Deviation 480
|
1930 ng/mL
Standard Deviation 652
|
3820 ng/mL
Standard Deviation 1550
|
6930 ng/mL
Standard Deviation 1950
|
7620 ng/mL
Standard Deviation 3350
|
10300 ng/mL
Standard Deviation 3170
|
7880 ng/mL
Standard Deviation 2910
|
2920 ng/mL
Standard Deviation 499
|
3190 ng/mL
Standard Deviation 1010
|
3450 ng/mL
Standard Deviation 1140
|
4200 ng/mL
Standard Deviation 1020
|
|
Maximum Observed Plasma Concentration (Cmax) of Encorafenib, Binimetinib, Ribociclib Metabolite of Binimetinib and Ribociclib: Phase 1b
Binimetinib
|
635 ng/mL
Standard Deviation 402
|
587 ng/mL
Standard Deviation 147
|
986 ng/mL
Standard Deviation 771
|
532 ng/mL
Standard Deviation 227
|
807 ng/mL
Standard Deviation 398
|
901 ng/mL
Standard Deviation 480
|
621 ng/mL
Standard Deviation 160
|
462 ng/mL
Standard Deviation 85.6
|
867 ng/mL
Standard Deviation 232
|
560 ng/mL
Standard Deviation 213
|
703 ng/mL
Standard Deviation 222
|
|
Maximum Observed Plasma Concentration (Cmax) of Encorafenib, Binimetinib, Ribociclib Metabolite of Binimetinib and Ribociclib: Phase 1b
Ribociclib
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
74.2 ng/mL
Standard Deviation 37.5
|
219 ng/mL
Standard Deviation 95.2
|
554 ng/mL
Standard Deviation 251
|
1220 ng/mL
Standard Deviation 701
|
|
Maximum Observed Plasma Concentration (Cmax) of Encorafenib, Binimetinib, Ribociclib Metabolite of Binimetinib and Ribociclib: Phase 1b
Metabolite of Binimetinib
|
79.3 ng/mL
Standard Deviation 55.3
|
75.3 ng/mL
Standard Deviation 10.7
|
90.8 ng/mL
Standard Deviation 88.0
|
67.9 ng/mL
Standard Deviation 32.0
|
85.1 ng/mL
Standard Deviation 34.9
|
93.5 ng/mL
Standard Deviation 67.0
|
81.1 ng/mL
Standard Deviation 32.4
|
41.8 ng/mL
Standard Deviation 13.2
|
83.2 ng/mL
Standard Deviation 28.2
|
40.2 ng/mL
Standard Deviation 22.3
|
45.0 ng/mL
Standard Deviation 25.4
|
|
Maximum Observed Plasma Concentration (Cmax) of Encorafenib, Binimetinib, Ribociclib Metabolite of Binimetinib and Ribociclib: Phase 1b
Metabolite of Ribociclib
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
5.90 ng/mL
Standard Deviation 1.73
|
28.7 ng/mL
Standard Deviation 7.82
|
58.0 ng/mL
Standard Deviation 39.6
|
73.8 ng/mL
Standard Deviation 24.3
|
SECONDARY outcome
Timeframe: Phase 1b: Pre dose,0.5,1.5,2.5,4,6,8 and 24 hr post dose on Day 15 of Cycle 1Population: FAS evaluated. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
Outcome measures
| Measure |
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
n=6 Participants
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 100 mg + Binimetinib 45 mg
n=5 Participants
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
n=4 Participants
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 400 mg + Binimetinib 45 mg
n=5 Participants
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 450 mg + Binimetinib 45 mg
n=13 Participants
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
n=8 Participants
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 800 mg + Binimetinib 45 mg
n=6 Participants
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 100 mg
n=4 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg + Ribociclib 200 mg
n=5 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 400 mg
n=6 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 600 mg
n=6 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax at Steady State (Cmax,ss) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Encorafenib
|
587 ng/mL
Standard Deviation 321
|
1190 ng/mL
Standard Deviation 409
|
1060 ng/mL
Standard Deviation 194
|
3760 ng/mL
Standard Deviation 1380
|
4320 ng/mL
Standard Deviation 2260
|
11100 ng/mL
Standard Deviation 14100
|
7320 ng/mL
Standard Deviation 2700
|
1670 ng/mL
Standard Deviation 453
|
2320 ng/mL
Standard Deviation 779
|
2480 ng/mL
Standard Deviation 1090
|
2590 ng/mL
Standard Deviation 929
|
|
Cmax at Steady State (Cmax,ss) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Binimetinib
|
693 ng/mL
Standard Deviation 283
|
568 ng/mL
Standard Deviation 233
|
616 ng/mL
Standard Deviation 438
|
553 ng/mL
Standard Deviation 336
|
638 ng/mL
Standard Deviation 283
|
716 ng/mL
Standard Deviation 321
|
726 ng/mL
Standard Deviation 206
|
584 ng/mL
Standard Deviation 181
|
778 ng/mL
Standard Deviation 160
|
563 ng/mL
Standard Deviation 262
|
609 ng/mL
Standard Deviation 261
|
|
Cmax at Steady State (Cmax,ss) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Ribociclib
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
43.7 ng/mL
Standard Deviation 16.1
|
146 ng/mL
Standard Deviation 111
|
493 ng/mL
Standard Deviation 258
|
752 ng/mL
Standard Deviation 304
|
|
Cmax at Steady State (Cmax,ss) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Metabolite of Binimetinib
|
39.7 ng/mL
Standard Deviation 43.7
|
36.0 ng/mL
Standard Deviation 25.9
|
27.3 ng/mL
Standard Deviation 12.6
|
31.7 ng/mL
Standard Deviation 25.9
|
38.8 ng/mL
Standard Deviation 21.8
|
35.0 ng/mL
Standard Deviation 25.3
|
47.3 ng/mL
Standard Deviation 19.5
|
38.3 ng/mL
Standard Deviation 25.4
|
55.1 ng/mL
Standard Deviation 26.5
|
33.2 ng/mL
Standard Deviation 16.7
|
33.7 ng/mL
Standard Deviation 12.8
|
|
Cmax at Steady State (Cmax,ss) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Metabolite of Ribociclib
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
16.8 ng/mL
Standard Deviation 9.77
|
49.7 ng/mL
Standard Deviation 19.5
|
155 ng/mL
Standard Deviation 30.5
|
195 ng/mL
Standard Deviation 56.3
|
SECONDARY outcome
Timeframe: Phase 1b: Pre dose, 0.5,1.5,2.5,4,6,8 and 24 hr post dose on Day 1 of Cycle 1Population: FAS evaluated. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
Outcome measures
| Measure |
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
n=6 Participants
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 100 mg + Binimetinib 45 mg
n=5 Participants
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
n=4 Participants
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 400 mg + Binimetinib 45 mg
n=5 Participants
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 450 mg + Binimetinib 45 mg
n=13 Participants
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
n=8 Participants
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 800 mg + Binimetinib 45 mg
n=6 Participants
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 100 mg
n=4 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg + Ribociclib 200 mg
n=5 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 400 mg
n=6 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 600 mg
n=6 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Elimination Half-life (t1/2) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Encorafenib
|
3.68 Hour
Standard Deviation 0.605
|
3.65 Hour
Standard Deviation 0.351
|
2.88 Hour
Standard Deviation 0.121
|
4.19 Hour
Standard Deviation 2.13
|
3.47 Hour
Standard Deviation 0.402
|
3.21 Hour
Standard Deviation 0.550
|
3.04 Hour
Standard Deviation 0.0935
|
3.25 Hour
Standard Deviation 0.375
|
2.10 Hour
Standard Deviation 0.451
|
2.95 Hour
Standard Deviation 1.13
|
2.59 Hour
Standard Deviation 0.567
|
|
Elimination Half-life (t1/2) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Binimetinib
|
2.36 Hour
Standard Deviation 0.427
|
2.37 Hour
Standard Deviation 0.704
|
2.10 Hour
Standard Deviation 0.522
|
2.51 Hour
Standard Deviation 0.472
|
2.22 Hour
Standard Deviation 0.439
|
2.12 Hour
Standard Deviation 0.314
|
1.99 Hour
Standard Deviation 0.601
|
3.73 Hour
Standard Deviation 1.78
|
2.45 Hour
Standard Deviation 1.19
|
3.11 Hour
Standard Deviation 1.01
|
1.98 Hour
Standard Deviation 0.523
|
|
Elimination Half-life (t1/2) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Ribociclib
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
8.71 Hour
Standard Deviation 2.32
|
7.97 Hour
Standard Deviation 1.24
|
10.3 Hour
Standard Deviation 3.94
|
7.71 Hour
Standard Deviation 0.408
|
|
Elimination Half-life (t1/2) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Metabolite of Binimetinib
|
2.82 Hour
Standard Deviation 0.757
|
2.00 Hour
Standard Deviation 0.0542
|
2.95 Hour
Standard Deviation 0.739
|
2.58 Hour
Standard Deviation 0.737
|
2.64 Hour
Standard Deviation 0.604
|
2.28 Hour
Standard Deviation 0.546
|
2.37 Hour
Standard Deviation 0.517
|
3.39 Hour
Standard Deviation 1.57
|
2.49 Hour
Standard Deviation 0.528
|
—
|
2.32 Hour
Standard Deviation 0.455
|
|
Elimination Half-life (t1/2) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Metabolite of Ribociclib
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
23.2 Hour
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was evaluable.
|
15.4 Hour
Standard Deviation 6.92
|
7.99 Hour
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was evaluable.
|
15.9 Hour
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was evaluable.
|
SECONDARY outcome
Timeframe: Phase 1b: Pre dose,0.5,1.5,2.5,4,6,8 and 24 hr post dose on Day 15 of Cycle 1Population: FAS evaluated. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
Outcome measures
| Measure |
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
n=6 Participants
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 100 mg + Binimetinib 45 mg
n=5 Participants
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
n=4 Participants
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 400 mg + Binimetinib 45 mg
n=5 Participants
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 450 mg + Binimetinib 45 mg
n=13 Participants
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
n=8 Participants
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 800 mg + Binimetinib 45 mg
n=6 Participants
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 100 mg
n=4 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg + Ribociclib 200 mg
n=5 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 400 mg
n=6 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 600 mg
n=6 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
t1/2 at Steady State (t1/2,ss) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Ribociclib
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
13.2 Hour
Standard Deviation 2.26
|
11.4 Hour
Standard Deviation 6.07
|
8.49 Hour
Standard Deviation 2.80
|
10.3 Hour
Standard Deviation 5.32
|
|
t1/2 at Steady State (t1/2,ss) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Encorafenib
|
4.74 Hour
Standard Deviation 1.18
|
4.47 Hour
Standard Deviation 0.380
|
4.32 Hour
Standard Deviation 1.25
|
4.21 Hour
Standard Deviation 0.724
|
3.57 Hour
Standard Deviation 0.688
|
3.40 Hour
Standard Deviation 0.223
|
3.37 Hour
Standard Deviation 0.511
|
3.98 Hour
Standard Deviation 0.331
|
3.24 Hour
Standard Deviation 0.776
|
4.00 Hour
Standard Deviation 0.922
|
3.52 Hour
Standard Deviation 0.237
|
|
t1/2 at Steady State (t1/2,ss) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Binimetinib
|
4.74 Hour
Standard Deviation 1.43
|
4.80 Hour
Standard Deviation 1.40
|
3.28 Hour
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was evaluable.
|
4.20 Hour
Standard Deviation 1.36
|
3.61 Hour
Standard Deviation 1.14
|
—
|
2.91 Hour
Standard Deviation 0.157
|
4.04 Hour
Standard Deviation 2.03
|
2.67 Hour
Standard Deviation 1.40
|
3.69 Hour
Standard Deviation 1.16
|
5.21 Hour
Standard Deviation 1.75
|
|
t1/2 at Steady State (t1/2,ss) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Metabolite of Binimetinib
|
4.51 Hour
Standard Deviation 1.23
|
7.23 Hour
Standard Deviation 5.44
|
2.07 Hour
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was evaluable.
|
4.61 Hour
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was evaluable.
|
2.79 Hour
Standard Deviation 1.23
|
4.06 Hour
Standard Deviation 0.195
|
3.33 Hour
Standard Deviation 0.524
|
5.12 Hour
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was evaluable.
|
2.58 Hour
Standard Deviation 0.626
|
3.44 Hour
Standard Deviation 0.115
|
4.38 Hour
Standard Deviation 2.14
|
|
t1/2 at Steady State (t1/2,ss) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Metabolite of Ribociclib
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
18.3 Hour
Standard Deviation 3.23
|
15.7 Hour
Standard Deviation 6.62
|
15.0 Hour
Standard Deviation 6.27
|
18.6 Hour
Standard Deviation 2.76
|
SECONDARY outcome
Timeframe: Phase 1b: Pre dose, 0.5,1.5,2.5,4,6,8 and 24 hr post dose on Day 1 and 15 of Cycle 1Population: FAS evaluated. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
Accumulation ratio was calculated as AUCtau,ss/AUCtau.
Outcome measures
| Measure |
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
n=6 Participants
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 100 mg + Binimetinib 45 mg
n=5 Participants
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
n=4 Participants
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 400 mg + Binimetinib 45 mg
n=5 Participants
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 450 mg + Binimetinib 45 mg
n=13 Participants
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
n=8 Participants
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 800 mg + Binimetinib 45 mg
n=6 Participants
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 100 mg
n=4 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg + Ribociclib 200 mg
n=5 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 400 mg
n=6 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 600 mg
n=6 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Accumulation Ratio (RA) of Encorafenib, Binimetinib, Ribociclib Metabolite of Binimetinib and Ribociclib: Phase 1b
Ribociclib
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.640 Ratio
Standard Deviation 0.282
|
0.734 Ratio
Standard Deviation 0.404
|
1.11 Ratio
Standard Deviation 0.753
|
0.712 Ratio
Standard Deviation 0.168
|
|
Accumulation Ratio (RA) of Encorafenib, Binimetinib, Ribociclib Metabolite of Binimetinib and Ribociclib: Phase 1b
Encorafenib
|
0.857 Ratio
Standard Deviation 0.351
|
0.601 Ratio
Standard Deviation 0.322
|
0.298 Ratio
Standard Deviation 0.0682
|
0.348 Ratio
Standard Deviation 0.125
|
0.458 Ratio
Standard Deviation 0.188
|
0.473 Ratio
Standard Deviation 0.215
|
0.690 Ratio
Standard Deviation 0.291
|
0.460 Ratio
Standard Deviation 0.134
|
0.841 Ratio
Standard Deviation 0.178
|
0.833 Ratio
Standard Deviation 0.463
|
0.806 Ratio
Standard Deviation 0.393
|
|
Accumulation Ratio (RA) of Encorafenib, Binimetinib, Ribociclib Metabolite of Binimetinib and Ribociclib: Phase 1b
Binimetinib
|
1.51 Ratio
Standard Deviation 0.248
|
1.26 Ratio
Standard Deviation 0.152
|
1.07 Ratio
Standard Deviation 0.142
|
0.989 Ratio
Standard Deviation 0.353
|
1.03 Ratio
Standard Deviation 0.339
|
0.969 Ratio
Standard Deviation 0.297
|
1.19 Ratio
Standard Deviation 0.472
|
1.29 Ratio
Standard Deviation 0.572
|
0.778 Ratio
Standard Deviation 0.102
|
1.19 Ratio
Standard Deviation 0.324
|
1.08 Ratio
Standard Deviation 0.316
|
|
Accumulation Ratio (RA) of Encorafenib, Binimetinib, Ribociclib Metabolite of Binimetinib and Ribociclib: Phase 1b
Metabolite of Binimetinib
|
0.899 Ratio
Standard Deviation 0.542
|
0.588 Ratio
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was evaluable.
|
0.285 Ratio
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was evaluable.
|
0.954 Ratio
Standard Deviation 0.0302
|
0.546 Ratio
Standard Deviation 0.300
|
0.499 Ratio
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was evaluable.
|
0.569 Ratio
Standard Deviation 0.0381
|
1.56 Ratio
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was evaluable.
|
0.726 Ratio
Standard Deviation 0.194
|
—
|
0.910 Ratio
Standard Deviation 0.195
|
|
Accumulation Ratio (RA) of Encorafenib, Binimetinib, Ribociclib Metabolite of Binimetinib and Ribociclib: Phase 1b
Metabolite of Ribociclib
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2.81 Ratio
Standard Deviation 0.619
|
1.93 Ratio
Standard Deviation 0.684
|
2.73 Ratio
Standard Deviation 0.517
|
2.97 Ratio
Standard Deviation 0.548
|
SECONDARY outcome
Timeframe: Phase 1b: From Day 1 of dosing till complete response or partial response achieved (maximum exposure of treatment in Phase 1b was 118.3 months)Population: FAS included all participants who received at least one dose of LGX818 or MEK162 or LEE011.
ORR was defined as the percentage of participants with a best overall response of CR or PR. As per RECIST v1.1, CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must have a reduction in short axis \<10 mm. PR was defined as \>= 30 % decrease under baseline of sum of diameters of all target lesions taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
n=6 Participants
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 100 mg + Binimetinib 45 mg
n=5 Participants
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
n=4 Participants
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 400 mg + Binimetinib 45 mg
n=5 Participants
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 450 mg + Binimetinib 45 mg
n=13 Participants
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
n=8 Participants
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 800 mg + Binimetinib 45 mg
n=6 Participants
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 100 mg
n=4 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg + Ribociclib 200 mg
n=5 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 400 mg
n=6 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 600 mg
n=6 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR): Phase 1b
|
66.7 Percentage of participants
Interval 22.3 to 95.7
|
40.0 Percentage of participants
Interval 5.3 to 85.3
|
25.0 Percentage of participants
Interval 0.6 to 80.6
|
40.0 Percentage of participants
Interval 5.3 to 85.3
|
53.8 Percentage of participants
Interval 25.1 to 80.8
|
25.0 Percentage of participants
Interval 3.2 to 65.1
|
50.0 Percentage of participants
Interval 11.8 to 88.2
|
75.0 Percentage of participants
Interval 19.4 to 99.4
|
60.0 Percentage of participants
Interval 14.7 to 94.7
|
66.7 Percentage of participants
Interval 22.3 to 95.7
|
66.7 Percentage of participants
Interval 22.3 to 95.7
|
SECONDARY outcome
Timeframe: Phase 2: From start of study drug until documented PD or death due to any cause or censoring date (maximum exposure of treatment in Phase 2 was 111.5 months)Population: FAS included all participants who received at least one dose of LGX818 or MEK162 or LEE011.
PFS was defined as the time from the start of study treatment to the date of the event defined as the first documented progression or death due to any cause. If a participant did not have an event, PFS was censored at the date of last adequate tumor assessment. Per RECIST 1.1, PD= At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm\^2. Unequivocal progression of existing non-target lesions. Kaplan-Meier method was used for analysis.
Outcome measures
| Measure |
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
n=11 Participants
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 100 mg + Binimetinib 45 mg
n=26 Participants
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
n=42 Participants
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 400 mg + Binimetinib 45 mg
n=42 Participants
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 450 mg + Binimetinib 45 mg
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 800 mg + Binimetinib 45 mg
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 100 mg
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg + Ribociclib 200 mg
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 400 mg
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 600 mg
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS): Phase 2
|
5.4 Months
Interval 2.1 to 9.0
|
3.8 Months
Interval 3.4 to 9.3
|
7.5 Months
Interval 5.7 to 12.2
|
9.0 Months
Interval 5.6 to 11.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Phase 2: From date of start of treatment until date of first documentation of objective tumor response (maximum exposure of treatment in Phase 2 was 111.5 months)Population: FAS evaluated.Here "Number of Participants Analyzed" signifies the number of participants who were confirmed responders and were evaluable for this outcome measure.
TTR was defined as the time from the first dose of study treatment to the first documentation of objective tumor response documented in participants with confirmed objective response (CR or PR). As per RECIST v1.1, CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must have a reduction in short axis \<10 mm. PR was defined as \>= 30 % decrease under baseline of sum of diameters of all target lesions taking as reference the baseline sum of diameters. Kaplan-Meier method was used for analysis.
Outcome measures
| Measure |
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
n=2 Participants
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 100 mg + Binimetinib 45 mg
n=11 Participants
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
n=28 Participants
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 400 mg + Binimetinib 45 mg
n=25 Participants
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 450 mg + Binimetinib 45 mg
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 800 mg + Binimetinib 45 mg
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 100 mg
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg + Ribociclib 200 mg
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 400 mg
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 600 mg
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Response (TTR): Phase 2
|
2.6 Months
Interval 1.6 to 3.6
|
1.8 Months
Interval 1.0 to 5.6
|
1.0 Months
Interval 1.0 to 1.8
|
1.9 Months
Interval 1.8 to 2.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Phase 2: From date of first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to underlying cancer, whichever occurred first (maximum exposure of treatment in Phase 2 was 111.5 months)Population: FAS evaluated.Here "Number of Participants Analyzed" signifies the number of participants who were confirmed responders and were evaluable for this outcome measure.
DOR was defined as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to underlying cancer, whichever occurred first in participants with confirmed objective response (CR or PR). As per RECIST v1.1, CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must have a reduction in short axis \<10 mm. PR was defined as \>= 30 % decrease under baseline of sum of diameters of all target lesions taking as reference the baseline sum of diameters. Kaplan-Meier method was used for analysis.
Outcome measures
| Measure |
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
n=2 Participants
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 100 mg + Binimetinib 45 mg
n=11 Participants
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
n=28 Participants
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 400 mg + Binimetinib 45 mg
n=25 Participants
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 450 mg + Binimetinib 45 mg
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 800 mg + Binimetinib 45 mg
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 100 mg
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg + Ribociclib 200 mg
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 400 mg
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 600 mg
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR): Phase 2
|
7.1 Months
Interval 3.8 to
Upper limit of CI could not be estimated because of insufficient number of participants with this event and hence could not be reported.
|
3.8 Months
Interval 2.9 to 12.9
|
10.9 Months
Interval 6.5 to 19.5
|
7.5 Months
Interval 5.6 to 25.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Phase 2: From date of start of study treatment until date of death or censoring date (maximum exposure of treatment in Phase 2 was 111.5 months)Population: FAS included all participants who received at least one dose of LGX818 or MEK162 or LEE011.
OS was defined as the time from date of randomization/start of treatment to date of death due to any cause. If a participant was not known to have died, survival was censored at the date of last contact. Analysis was performed using Kaplan-Meier method.
Outcome measures
| Measure |
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
n=11 Participants
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 100 mg + Binimetinib 45 mg
n=26 Participants
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
n=42 Participants
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 400 mg + Binimetinib 45 mg
n=42 Participants
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 450 mg + Binimetinib 45 mg
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 800 mg + Binimetinib 45 mg
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 100 mg
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg + Ribociclib 200 mg
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 400 mg
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 600 mg
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS): Phase 2
|
9.5 Months
Interval 7.7 to 27.2
|
11.4 Months
Interval 5.9 to 20.7
|
23.1 Months
Interval 17.3 to
Upper limit of CI could not be estimated because of insufficient number of participants with this event and hence could not be reported.
|
21.8 Months
Interval 14.8 to 35.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Phase 1b: BaselinePopulation: FAS included all participants who received at least one dose of LGX818 or MEK162 or LEE011.
Molecular alterations of tumor tissues was determined using the following potential predictive markers: Biomarkers like V-raf murine sarcoma viral oncogene homolog B1 (BRAF),V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS), Phosphatase and tensin homolog (PTEN), Phosphatidylinositol 3' kinase catalytic alphapolypeptide (PIK3CA), Epidermal growth factor receptor (EGFR).
Outcome measures
| Measure |
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
n=6 Participants
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 100 mg + Binimetinib 45 mg
n=5 Participants
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
n=4 Participants
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 400 mg + Binimetinib 45 mg
n=5 Participants
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 450 mg + Binimetinib 45 mg
n=13 Participants
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
n=8 Participants
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 800 mg + Binimetinib 45 mg
n=6 Participants
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 100 mg
n=4 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg + Ribociclib 200 mg
n=5 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 400 mg
n=6 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 600 mg
n=6 Participants
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Molecular Alterations of Tumor Tissues Using Potential Predictive Markers: Phase 1b
BRAF
|
5 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
7 Participants
|
7 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Molecular Alterations of Tumor Tissues Using Potential Predictive Markers: Phase 1b
KRAS
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Molecular Alterations of Tumor Tissues Using Potential Predictive Markers: Phase 1b
PTEN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Molecular Alterations of Tumor Tissues Using Potential Predictive Markers: Phase 1b
PIK3CA
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Molecular Alterations of Tumor Tissues Using Potential Predictive Markers: Phase 1b
EGFR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Phase 2: BaselinePopulation: FAS included all participants who received at least one dose of LGX818 or MEK162 or LEE011.
Molecular alterations of tumor tissues was determined using the following potential predictive markers: BRAF, HRAS, KRAS, Neuroblastoma RAS viral oncogene homolog (NRAS), PTEN, PIK3CA, Mitogen-activated protein kinase 1 (MAP2K1), Mitogen-activated protein kinase 2 (MAP2K2), EGFR.
Outcome measures
| Measure |
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
n=11 Participants
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 100 mg + Binimetinib 45 mg
n=26 Participants
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
n=42 Participants
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 400 mg + Binimetinib 45 mg
n=42 Participants
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 450 mg + Binimetinib 45 mg
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 800 mg + Binimetinib 45 mg
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 100 mg
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg + Ribociclib 200 mg
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 400 mg
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg+ Ribociclib 600 mg
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Molecular Alterations of Tumor Tissues Using Potential Predictive Markers: Phase 2
ARAF
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Molecular Alterations of Tumor Tissues Using Potential Predictive Markers: Phase 2
BRAF
|
4 Participants
|
15 Participants
|
20 Participants
|
30 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Molecular Alterations of Tumor Tissues Using Potential Predictive Markers: Phase 2
HRAS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Molecular Alterations of Tumor Tissues Using Potential Predictive Markers: Phase 2
KRAS
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Molecular Alterations of Tumor Tissues Using Potential Predictive Markers: Phase 2
NRAS
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Molecular Alterations of Tumor Tissues Using Potential Predictive Markers: Phase 2
PTEN
|
1 Participants
|
6 Participants
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Molecular Alterations of Tumor Tissues Using Potential Predictive Markers: Phase 2
PIK3CA
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Molecular Alterations of Tumor Tissues Using Potential Predictive Markers: Phase 2
MAP2K1
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Molecular Alterations of Tumor Tissues Using Potential Predictive Markers: Phase 2
MAP2K2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Molecular Alterations of Tumor Tissues Using Potential Predictive Markers: Phase 2
EGFR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
Serious events: 4 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase 1b: Encorafenib 100 mg+ Binimetinib 45 mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Phase 1b: Encorafenib 400 mg + Binimetinib 45 mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 2 deaths
Phase 1b: Encorafenib 450 mg+ Binimetinib 45 mg
Serious events: 5 serious events
Other events: 13 other events
Deaths: 2 deaths
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Phase 1b: Encorafenib 800 mg + Binimetinib 45 mg
Serious events: 4 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 100 mg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 200 mg
Serious events: 3 serious events
Other events: 5 other events
Deaths: 1 deaths
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 400 mg
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg + Ribociclib 600 mg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 2 deaths
Phase 2: Arm 1 (mCRC): Encorafenib + Binimetinib
Serious events: 5 serious events
Other events: 11 other events
Deaths: 9 deaths
Phase 2: Arm 2 (Prior BRAFi Melanoma): Encorafenib + Binimetinib
Serious events: 13 serious events
Other events: 26 other events
Deaths: 22 deaths
Phase 2: Arm 3 (BRAFi-naïve Melanoma): Encorafenib + Binimetinib
Serious events: 18 serious events
Other events: 39 other events
Deaths: 22 deaths
Phase 2: Arm A (BRAFi-naïve Melanoma): Encorafenib + Binimetinib + Ribociclib
Serious events: 21 serious events
Other events: 42 other events
Deaths: 28 deaths
Serious adverse events
| Measure |
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
n=6 participants at risk
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 100 mg+ Binimetinib 45 mg
n=5 participants at risk
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
n=4 participants at risk
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 400 mg + Binimetinib 45 mg
n=5 participants at risk
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 450 mg+ Binimetinib 45 mg
n=13 participants at risk
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
n=8 participants at risk
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 800 mg + Binimetinib 45 mg
n=6 participants at risk
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 100 mg
n=4 participants at risk
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on, 1 week off schedule.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 200 mg
n=5 participants at risk
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on, 1 week off schedule.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 400 mg
n=6 participants at risk
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on, 1 week off schedule.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg + Ribociclib 600 mg
n=6 participants at risk
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on, 1 week off schedule.
|
Phase 2: Arm 1 (mCRC): Encorafenib + Binimetinib
n=11 participants at risk
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
|
Phase 2: Arm 2 (Prior BRAFi Melanoma): Encorafenib + Binimetinib
n=26 participants at risk
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks.
|
Phase 2: Arm 3 (BRAFi-naïve Melanoma): Encorafenib + Binimetinib
n=42 participants at risk
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks.
|
Phase 2: Arm A (BRAFi-naïve Melanoma): Encorafenib + Binimetinib + Ribociclib
n=42 participants at risk
Participants received Encorafenib 200 mg QD (MTD), Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks, and Ribociclib 600 mg QD orally for 3 weeks on, 1 week off schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
11.5%
3/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
4.8%
2/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
4.8%
2/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Cardiac disorders
Intracardiac mass
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Eye disorders
Retinal vein occlusion
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Eye disorders
Retinopathy hypertensive
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
18.2%
2/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Melaena
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
11.5%
3/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
4.8%
2/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
General disorders
Pyrexia
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
2/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
4.8%
2/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Hepatobiliary disorders
Cholecystitis
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Infections and infestations
Pharyngeal abscess
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Infections and infestations
Pyelonephritis
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Infections and infestations
Septic shock
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Bone disorder
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Nervous system disorders
Balance disorder
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Nervous system disorders
Hemiparesis
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Nervous system disorders
Nerve root compression
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Nervous system disorders
Seizure
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Nervous system disorders
Transient ischaemic attack
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Psychiatric disorders
Suicide attempt
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Eye disorders
Blindness
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Eye disorders
Eye pain
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Eye disorders
Iritis
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Eye disorders
Visual impairment
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Eye disorders
Detachment of retinal pigment epithelium
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Eye disorders
Macular oedema
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
General disorders
Axillary pain
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
General disorders
Chills
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
General disorders
General physical health deterioration
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
4.8%
2/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
General disorders
Disease progression
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Hepatobiliary disorders
Hepatic haemorrhage
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Infections and infestations
Dermo-hypodermitis
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial tumour haemorrhage
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
4.8%
2/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
4.8%
2/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
4.8%
2/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Surgical and medical procedures
Lymphadenectomy
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Investigations
Troponin increased
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
2/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Investigations
Mediastinoscopy
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
Other adverse events
| Measure |
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
n=6 participants at risk
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 100 mg+ Binimetinib 45 mg
n=5 participants at risk
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
n=4 participants at risk
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 400 mg + Binimetinib 45 mg
n=5 participants at risk
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 450 mg+ Binimetinib 45 mg
n=13 participants at risk
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
n=8 participants at risk
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 800 mg + Binimetinib 45 mg
n=6 participants at risk
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 100 mg
n=4 participants at risk
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on, 1 week off schedule.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 200 mg
n=5 participants at risk
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on, 1 week off schedule.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg+ Ribociclib 400 mg
n=6 participants at risk
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on, 1 week off schedule.
|
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg + Ribociclib 600 mg
n=6 participants at risk
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on, 1 week off schedule.
|
Phase 2: Arm 1 (mCRC): Encorafenib + Binimetinib
n=11 participants at risk
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
|
Phase 2: Arm 2 (Prior BRAFi Melanoma): Encorafenib + Binimetinib
n=26 participants at risk
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks.
|
Phase 2: Arm 3 (BRAFi-naïve Melanoma): Encorafenib + Binimetinib
n=42 participants at risk
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks.
|
Phase 2: Arm A (BRAFi-naïve Melanoma): Encorafenib + Binimetinib + Ribociclib
n=42 participants at risk
Participants received Encorafenib 200 mg QD (MTD), Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks, and Ribociclib 600 mg QD orally for 3 weeks on, 1 week off schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
37.5%
3/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
23.1%
6/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
7/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
26.2%
11/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
40.5%
17/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Eye disorders
Detachment of retinal pigment epithelium
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
75.0%
3/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
26.9%
7/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
11.9%
5/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
4.8%
2/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Eye disorders
Macular oedema
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
75.0%
3/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
15.4%
4/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
11.9%
5/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
11.9%
5/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Eye disorders
Chorioretinopathy
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
15.4%
2/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
18.2%
2/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
11.5%
3/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
4.8%
2/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Eye disorders
Photophobia
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
2/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Eye disorders
Retinopathy
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
63.6%
7/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
15.4%
4/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
14.3%
6/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
21.4%
9/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Eye disorders
Subretinal fluid
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
30.8%
4/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
15.4%
4/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
21.4%
9/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Eye disorders
Vision blurred
|
50.0%
3/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
2/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
50.0%
3/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
19.2%
5/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
28.6%
12/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Eye disorders
Visual impairment
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
2/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
50.0%
2/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
15.4%
4/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
14.3%
6/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Eye disorders
Cataract
|
50.0%
3/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Eye disorders
Dry eye
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
23.1%
3/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Ear and labyrinth disorders
Ear pain
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
15.4%
2/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
3/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
30.8%
4/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
2/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
50.0%
3/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
2/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
26.2%
11/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
14.3%
6/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
50.0%
3/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
11.9%
5/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
3/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
60.0%
3/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
50.0%
2/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
30.8%
4/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
37.5%
3/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
66.7%
4/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
50.0%
2/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
36.4%
4/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
19.2%
5/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
31.0%
13/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
28.6%
12/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
4/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
53.8%
7/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
87.5%
7/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
66.7%
4/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
50.0%
3/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
66.7%
4/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
72.7%
8/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
53.8%
14/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
47.6%
20/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
42.9%
18/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
23.1%
3/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.5%
4/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.5%
4/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
7/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
4.8%
2/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
80.0%
4/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
50.0%
2/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
53.8%
7/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
62.5%
5/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
50.0%
3/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
50.0%
2/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
54.5%
6/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
42.3%
11/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
47.6%
20/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
40.5%
17/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
100.0%
4/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
53.8%
7/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
37.5%
3/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
63.6%
7/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
34.6%
9/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
14/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
38.1%
16/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Abdominal distension
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
11.5%
3/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Flatulence
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
15.4%
2/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.5%
4/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Eye disorders
Retinal degeneration
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
15.4%
2/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
2/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
15.4%
2/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Stomatitis
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
General disorders
Asthenia
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
63.6%
7/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
11.5%
3/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
21.4%
9/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
General disorders
Fatigue
|
66.7%
4/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
53.8%
7/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
37.5%
3/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
50.0%
3/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
50.0%
2/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
18.2%
2/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
38.5%
10/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
28.6%
12/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
14/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
2/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.5%
4/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
General disorders
Oedema peripheral
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
2/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
15.4%
4/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
7/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
General disorders
Chills
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
23.1%
3/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
18.2%
2/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
19.2%
5/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
7/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.5%
4/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
General disorders
Pyrexia
|
66.7%
4/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
30.8%
4/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
50.0%
2/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
60.0%
3/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
54.5%
6/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
15.4%
4/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
14/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
28.6%
12/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
General disorders
Peripheral swelling
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
4.8%
2/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.5%
4/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
15.4%
2/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
4.8%
2/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
4.8%
2/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
15.4%
2/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
36.4%
4/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
15.4%
4/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
4.8%
2/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Infections and infestations
Influenza
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
15.4%
2/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
37.5%
3/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
19.2%
5/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
26.2%
11/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
26.2%
11/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
37.5%
3/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
23.1%
6/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
28.6%
12/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
23.8%
10/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Investigations
Blood creatine phosphokinase increased
|
50.0%
3/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
60.0%
3/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
50.0%
3/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
23.1%
6/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
35.7%
15/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
26.2%
11/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
7/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
21.4%
9/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Investigations
Lipase increased
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
23.1%
3/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
14/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.5%
4/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.5%
4/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.5%
4/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
2/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.5%
4/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Investigations
Amylase increased
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
14.3%
6/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Investigations
Weight increased
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
15.4%
2/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
14.3%
6/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
23.1%
6/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
28.6%
12/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Investigations
Weight decreased
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
50.0%
3/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
36.4%
4/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.5%
4/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
19.0%
8/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.5%
4/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
15.4%
2/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
2/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
14.3%
6/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
27.3%
3/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
15.4%
2/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
11.5%
3/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
11.5%
3/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
4.8%
2/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
2/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
4.8%
2/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
11.9%
5/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
18.2%
2/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
11.5%
3/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.5%
4/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
2/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
2/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
3/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
60.0%
3/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
15.4%
2/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
50.0%
2/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
60.0%
3/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
36.4%
4/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
26.9%
7/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
35.7%
15/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
14.3%
6/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
15.4%
2/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
2/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
36.4%
4/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
19.2%
5/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
19.0%
8/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
7/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
23.1%
3/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
2/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
50.0%
2/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
7/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.5%
4/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
23.1%
3/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.5%
4/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
15.4%
2/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
2/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
50.0%
3/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
50.0%
2/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
60.0%
3/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
2/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
7/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.5%
4/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
50.0%
2/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
15.4%
2/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
50.0%
3/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
50.0%
2/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
19.2%
5/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
11.9%
5/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
19.0%
8/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
2/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
4.8%
2/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
2/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
15.4%
2/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Nervous system disorders
Dysgeusia
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
15.4%
2/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
4.8%
2/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
14.3%
6/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
23.1%
3/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
2/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
83.3%
5/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
19.0%
8/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
23.8%
10/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
15.4%
2/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
2/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
18.2%
2/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
21.4%
9/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Nervous system disorders
Paraesthesia
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
11.9%
5/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Nervous system disorders
Hypoaesthesia
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Nervous system disorders
Memory impairment
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Nervous system disorders
Migraine
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Nervous system disorders
Presyncope
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
2/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
30.8%
4/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.5%
4/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
66.7%
4/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
60.0%
3/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
15.4%
2/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
27.3%
3/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
23.1%
6/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
26.2%
11/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
37.5%
3/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
7/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
11.9%
5/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
15.4%
2/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
18.2%
2/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
4.8%
2/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
27.3%
3/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
2/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
2.4%
1/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
15.4%
2/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
18.2%
2/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Renal and urinary disorders
Pollakiuria
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
23.1%
3/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
40.0%
2/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
50.0%
2/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
19.0%
8/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
15.4%
2/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
50.0%
3/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
15.4%
4/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
26.2%
11/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
11.9%
5/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
15.4%
2/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
11.5%
3/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
11.9%
5/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
11.9%
5/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.5%
4/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
15.4%
2/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
11.5%
3/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
28.6%
12/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.5%
4/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
1/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
23.1%
3/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
50.0%
2/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
34.6%
9/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
19.0%
8/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
7/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Skin and subcutaneous tissue disorders
Hair texture abnormal
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
2/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.5%
4/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
15.4%
2/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Skin and subcutaneous tissue disorders
Palmoplantar keratoderma
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
23.1%
3/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
23.1%
3/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
23.1%
3/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Vascular disorders
Hypertension
|
50.0%
3/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
23.1%
3/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
21.4%
9/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
21.4%
9/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
25.0%
2/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Vascular disorders
Hot flush
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Vascular disorders
Hypotension
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Nervous system disorders
Disturbance in attention
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
3.8%
1/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.1%
3/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
7.7%
1/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
15.4%
2/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
12.5%
1/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
Eye disorders
Uveitis
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
20.0%
1/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.5%
4/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
|
General disorders
Chest pain
|
33.3%
2/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/13 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/8 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
16.7%
1/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/4 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/5 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/6 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.1%
1/11 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/26 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
9.5%
4/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
0.00%
0/42 • Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER