Trial Outcomes & Findings for A Study to Compare Tablets and Capsules of Orforglipron (LY3502970) in Healthy Participants Who Are Obese or Overweight (NCT NCT06440980)
NCT ID: NCT06440980
Last Updated: 2026-07-17
Results Overview
PK: Area under the concentration versus time curve from time 0 to the end of the once daily dosing interval at steady state AUC\[0-tau\] on Day 7.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
533 participants
Primary outcome timeframe
Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose on Day 7 for each dosing treatment period (1 period=7 days)
Results posted on
2026-07-17
Participant Flow
This study enrolled 533 participants across 4 mutually exclusive cohorts in 2 parts: Part A (pilot relative bioavailability; Cohorts 1A and 2A) and Part B (bioequivalence; Cohorts 1B and 2B). As per sponsor decision, for Part A tablet (Cohorts 1A and 2A), dose levels are presented as Dose Level 1 through Dose Level 18, where Dose Level 1 represents the lowest dose and Dose Level 18 represents the highest dose.
Part A: Cohorts 1A and 2A (each N=52) followed a 4-sequence crossover (12 and 18 periods); Cohort 2A included home (Periods 1-6) and inpatient dosing (Periods 7-18). Part B: Cohorts 1B (N=216; 9 periods) and 2B (N=213; 15 periods) followed a 3-sequence crossover; Cohort 2B included home (Periods 1-6) and inpatient dosing (Periods 7-15).
Participant milestones
| Measure |
Part A: LY3502970 QD Oral Administration (Cohort 1A, Sequence 1)
Participants received LY3502970 orally once daily (QD) across inpatient Treatment Periods 1-12 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows:
* Period 1: 1 mg (Capsule)
* Period 2: Dose Level 2 (Tablet)
* Period 3: Dose Level 1 (Tablet)
* Period 4: Dose Level 3 (Tablet)
* Period 5: 3 mg (Capsule)
* Period 6: Dose Level 5 (Tablet)
* Period 7: Dose Level 4 (Tablet)
* Period 8: Dose Level 6 (Tablet)
* Period 9: 6 mg (Capsule)
* Period 10: Dose Level 8 (Tablet)
* Period 11: Dose Level 7 (Tablet)
* Period 12: Dose Level 9 (Tablet)
|
Part A: LY3502970 Oral Administration (Cohort 1A, Sequence 2)
Participants received LY3502970 orally QD across inpatient Treatment Periods 1-12 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows:
* Period 1: Dose Level 2 (Tablet)
* Period 2: 1 mg (Capsule)
* Period 3: Dose Level 3 (Tablet)
* Period 4: Dose Level 1 (Tablet)
* Period 5: Dose Level 5 (Tablet)
* Period 6: 3 mg (Capsule)
* Period 7: Dose Level 6 (Tablet)
* Period 8: Dose Level 4 (Tablet)
* Period 9: Dose Level 8 (Tablet)
* Period 10: 6 mg (Capsule)
* Period 11: Dose Level 9 (Tablet)
* Period 12: Dose Level 7 (Tablet)
|
Part A: LY3502970 Oral Administration (Cohort 1A, Sequence 3)
Participants received LY3502970 orally QD across inpatient Treatment Periods 1-12 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows:
* Period 1: Dose Level 1 (Tablet)
* Period 2: Dose Level 3 (Tablet)
* Period 3: 1 mg (Capsule)
* Period 4: Dose Level 2 (Tablet)
* Period 5: Dose Level 4 (Tablet)
* Period 6: Dose Level 6 (Tablet)
* Period 7: 3 mg (Capsule)
* Period 8: Dose Level 5 (Tablet)
* Period 9: Dose Level 7 (Tablet)
* Period 10: Dose Level 9 (Tablet)
* Period 11: 6 mg (Capsule)
* Period 12: Dose Level 8 (Tablet)
|
Part A: LY3502970 Oral Administration (Cohort 1A, Sequence 4)
Participants received LY3502970 orally QD across inpatient Treatment Periods 1-12 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows:
* Period 1: Dose Level 3 (Tablet)
* Period 2: Dose Level 1 (Tablet)
* Period 3: Dose Level 2 (Tablet)
* Period 4: 1 mg (Capsule)
* Period 5: Dose Level 6 (Tablet)
* Period 6: Dose Level 4 (Tablet)
* Period 7: Dose Level 5 (Tablet)
* Period 8: 3 mg (Capsule)
* Period 9: Dose Level 9 (Tablet)
* Period 10: Dose Level 7 (Tablet)
* Period 11: Dose Level 8 (Tablet)
* Period 12: 6 mg (Capsule)
|
Part A: LY3502970 Oral Administration (Cohort 2A, Sequence 1)
Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg and 6 mg; Capsule), followed by inpatient Treatment Periods 7-18 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows:
* Period 7: 12 mg (Capsule)
* Period 8: Dose Level 11 (Tablet)
* Period 9: Dose Level 10 (Tablet)
* Period 10: Dose Level 12 (Tablet)
* Period 11: 24 mg (Capsule)
* Period 12: Dose Level 14 (Tablet)
* Period 13: Dose Level 13 (Tablet)
* Period 14: Dose Level 15 (Tablet)
* Period 15: 36 mg (Capsule)
* Period 16: Dose Level 17 (Tablet)
* Period 17: Dose Level 16 (Tablet)
* Period 18: Dose Level 18 (Tablet)
|
Part A: LY3502970 Oral Administration (Cohort 2A, Sequence 2)
Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg, and 6 mg; Capsule), followed by inpatient Treatment Periods 7-18 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows:
* Period 7: Dose Level 11 (Tablet)
* Period 8: 12 mg (Capsule)
* Period 9: Dose Level 12 (Tablet)
* Period 10: Dose Level 10 (Tablet)
* Period 11: Dose Level 14 (Tablet)
* Period 12: 24 mg (Capsule)
* Period 13: Dose Level 15 (Tablet)
* Period 14: Dose Level 13 (Tablet)
* Period 15: Dose Level 17 (Tablet)
* Period 16: 36 mg (Capsule)
* Period 17: Dose Level 18 (Tablet)
* Period 18: Dose Level 16 (Tablet)
|
Part A: LY3502970 Oral Administration (Cohort 2A, Sequence 3)
Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg and 6 mg; Capsule), followed by inpatient Treatment Periods 7-18 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows:
* Period 7: Dose Level 10 (Tablet)
* Period 8: Dose Level 12 (Tablet)
* Period 9: 12 mg (Capsule)
* Period 10: Dose Level 11 (Tablet)
* Period 11: Dose Level 13 (Tablet)
* Period 12: Dose Level 15 (Tablet)
* Period 13: 24 mg (Capsule)
* Period 14: Dose Level 14 (Tablet)
* Period 15: Dose Level 16 (Tablet)
* Period 16: Dose Level 18 (Tablet)
* Period 17: 36 mg (Capsule)
* Period 18: Dose Level 17 (Tablet)
|
Part A: LY3502970 Oral Administration (Cohort 2A, Sequence 4)
Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg, and 6 mg; Capsule), followed by inpatient Treatment Periods 7-18 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows:
* Period 7: Dose Level 12 (Tablet)
* Period 8: Dose Level 10 (Tablet)
* Period 9: Dose Level 11 (Tablet)
* Period 10: 12 mg (Capsule)
* Period 11: Dose Level 15 (Tablet)
* Period 12: Dose Level 13 (Tablet)
* Period 13: Dose Level 14 (Tablet)
* Period 14: 24 mg (Capsule)
* Period 15: Dose Level 18 (Tablet)
* Period 16: Dose Level 15 (Tablet)
* Period 17: Dose Level 17 (Tablet)
* Period 18: 36 mg (Capsule)
|
Part B: LY3502970 Oral Administration (Cohort 1B, Sequence 1)
Participants received LY3502970 orally QD across inpatient Treatment Periods 1-9 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows:
* Period 1: 1 mg (Capsule- First Treatment)
* Period 2: 1 mg (Capsule- Second Treatment)
* Period 3: 0.8 mg (Tablet)
* Period 4: 3 mg (Capsule- First Treatment)
* Period 5: 3 mg (Capsule- Second Treatment)
* Period 6: 2.5 mg (Tablet)
* Period 7: 6 mg (Capsule- First Treatment)
* Period 8: 6 mg (Capsule- Second Treatment)
* Period 9: 5.5 mg (Tablet)
|
Part B: LY3502970 Oral Administration (Cohort 1B, Sequence 2)
Participants received LY3502970 orally QD across inpatient Treatment Periods 1-9 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows:
* Period 1: 1 mg (Capsule- First Treatment)
* Period 2: 0.8 mg (Tablet)
* Period 3: 1 mg (Capsule- Second Treatment)
* Period 4: 3 mg (Capsule- First Treatment)
* Period 5: 2.5 mg (Tablet)
* Period 6: 3 mg (Capsule- Second Treatment)
* Period 7: 6 mg (Capsule- First Treatment)
* Period 8: 5.5 mg (Tablet)
* Period 9: 6 mg (Capsule- Second Treatment)
|
Part B: LY3502970 Oral Administration (Cohort 1B, Sequence 3)
Participants received LY3502970 orally QD across inpatient Treatment Periods 1-9 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows:
* Period 1: 0.8 mg (Tablet)
* Period 2: 1 mg (Capsule- First Treatment)
* Period 3: 1 mg (Capsule- Second Treatment)
* Period 4: 2.5 mg (Tablet)
* Period 5: 3 mg (Capsule- First Treatment)
* Period 6: 3 mg (Capsule- Second Treatment)
* Period 7: 5.5 mg (Tablet)
* Period 8: 6 mg (Capsule- First Treatment)
* Period 9: 6 mg (Capsule- Second Treatment)
|
Part B: LY3502970 Oral Administration (Cohort 2B, Sequence 1)
Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg, and 6 mg \[Capsule\]), followed by inpatient Treatment Periods 7-15 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows:
* Period 7: 12 mg (Capsule- First Treatment)
* Period 8: 12 mg (Capsule- Second Treatment)
* Period 9: 9 mg (Tablet)
* Period 10: 24 mg (Capsule- First Treatment)
* Period 11: 24 mg (Capsule- Second Treatment)
* Period 12: 14.5 mg (Tablet)
* Period 13: 36 mg (Capsule- First Treatment)
* Period 14: 36 mg (Capsule- Second Treatment)
* Period 15: 17.2 mg (Tablet)
|
Part B: LY3502970 Oral Administration (Cohort 2B, Sequence 2)
Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg, and 6 mg \[Capsule\]), followed by inpatient Treatment Periods 7-15 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows:
* Period 7: 12 mg (Capsule- First Treatment)
* Period 8: 9 mg (Tablet)
* Period 9: 12 mg (Capsule- Second Treatment)
* Period 10: 24 mg (Capsule- First Treatment)
* Period 11: 14.5 mg (Tablet)
* Period 12: 24 mg (Capsule- Second Treatment)
* Period 13: 36 mg (Capsule- First Treatment)
* Period 14: 17.2 mg (Tablet)
* Period 15: 36 mg (Capsule- Second Treatment)
|
Part B: LY3502970 Oral Administration (Cohort 2B, Sequence 3)
Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg, and 6 mg \[Capsule\]), followed by inpatient Treatment Periods 7-15 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows:
* Period 7: 9 mg (Tablet)
* Period 8: 12 mg (Capsule- First Treatment)
* Period 9: 12 mg (Capsule- Second Treatment)
* Period 10: 14.5 mg (Tablet)
* Period 11: 24 mg (Capsule- First Treatment)
* Period 12: 24 mg (Capsule- Second Treatment)
* Period 13: 17.2 mg (Tablet)
* Period 14: 36 mg (Capsule- First Treatment)
* Period 15: 36 mg (Capsule- Second Treatment)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Cohort 1A
STARTED
|
13
|
13
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13
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13
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Cohort 1A
Period 1
|
13
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13
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13
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13
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Cohort 1A
Period 2
|
13
|
13
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13
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13
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Cohort 1A
Period 3
|
13
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13
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13
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13
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Cohort 1A
Period 4
|
13
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13
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13
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13
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Cohort 1A
Period 5
|
13
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13
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12
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13
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Cohort 1A
Period 6
|
13
|
13
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12
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13
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Cohort 1A
Period 7
|
13
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13
|
10
|
12
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Cohort 2A
STARTED
|
0
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0
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0
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0
|
15
|
12
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13
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12
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0
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0
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0
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0
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0
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0
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Cohort 1A
Period 8
|
13
|
13
|
10
|
11
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Cohort 1A
Period 9
|
13
|
13
|
10
|
11
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Cohort 1A
Period 10
|
13
|
12
|
10
|
11
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0
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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Cohort 1A
Period 11
|
13
|
12
|
10
|
11
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Cohort 1A
Period 12
|
13
|
12
|
10
|
11
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0
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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|
Cohort 1A
COMPLETED
|
13
|
12
|
10
|
10
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0
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0
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0
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0
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0
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0
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0
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0
|
0
|
0
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|
Cohort 1A
NOT COMPLETED
|
0
|
1
|
3
|
3
|
0
|
0
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0
|
0
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0
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0
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0
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0
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0
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0
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Cohort 2A
Home-Dosing (Period 1-6)
|
0
|
0
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0
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0
|
15
|
12
|
13
|
12
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0
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0
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0
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0
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0
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0
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Cohort 2A
Period 7
|
0
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0
|
0
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0
|
13
|
12
|
13
|
12
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0
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0
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0
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0
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0
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0
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Cohort 2A
Period 8
|
0
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0
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0
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0
|
13
|
12
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13
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12
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0
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0
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0
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0
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0
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0
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Cohort 2A
Period 9
|
0
|
0
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0
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0
|
13
|
12
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13
|
12
|
0
|
0
|
0
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0
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0
|
0
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|
Cohort 2A
NOT COMPLETED
|
0
|
0
|
0
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0
|
4
|
2
|
1
|
0
|
0
|
0
|
0
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0
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0
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0
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Cohort 2A
Period 10
|
0
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0
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0
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0
|
13
|
12
|
13
|
12
|
0
|
0
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0
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0
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0
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0
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Cohort 2A
Period 11
|
0
|
0
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0
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0
|
13
|
12
|
13
|
12
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0
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0
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0
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0
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0
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0
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Cohort 2A
Period 12
|
0
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0
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0
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0
|
13
|
12
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13
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12
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0
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0
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0
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0
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0
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0
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Cohort 2A
Period 13
|
0
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0
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0
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0
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13
|
12
|
13
|
12
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0
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0
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0
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0
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0
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0
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Cohort 2A
Period 14
|
0
|
0
|
0
|
0
|
13
|
11
|
12
|
12
|
0
|
0
|
0
|
0
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0
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0
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Cohort 2A
Period 15
|
0
|
0
|
0
|
0
|
11
|
10
|
12
|
12
|
0
|
0
|
0
|
0
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0
|
0
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Cohort 2A
Period 16
|
0
|
0
|
0
|
0
|
11
|
10
|
12
|
12
|
0
|
0
|
0
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0
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0
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0
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Cohort 2A
Period 17
|
0
|
0
|
0
|
0
|
11
|
10
|
12
|
12
|
0
|
0
|
0
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0
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0
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0
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Cohort 2A
Period 18
|
0
|
0
|
0
|
0
|
11
|
10
|
12
|
12
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 2A
COMPLETED
|
0
|
0
|
0
|
0
|
11
|
10
|
12
|
12
|
0
|
0
|
0
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0
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0
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0
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Cohort 1B
STARTED
|
0
|
0
|
0
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0
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0
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0
|
0
|
0
|
72
|
72
|
72
|
0
|
0
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0
|
|
Cohort 1B
Period 1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
72
|
72
|
72
|
0
|
0
|
0
|
|
Cohort 1B
Period 2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
71
|
70
|
71
|
0
|
0
|
0
|
|
Cohort 1B
Period 3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
71
|
69
|
71
|
0
|
0
|
0
|
|
Cohort 1B
Period 4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
71
|
69
|
71
|
0
|
0
|
0
|
|
Cohort 1B
Period 5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
71
|
68
|
70
|
0
|
0
|
0
|
|
Cohort 1B
Period 6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
71
|
67
|
69
|
0
|
0
|
0
|
|
Cohort 1B
Period 7
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
70
|
67
|
68
|
0
|
0
|
0
|
|
Cohort 1B
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
8
|
6
|
0
|
0
|
0
|
|
Cohort 1B
Period 8
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
69
|
66
|
66
|
0
|
0
|
0
|
|
Cohort 1B
Period 9
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
69
|
65
|
66
|
0
|
0
|
0
|
|
Cohort 1B
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
69
|
64
|
66
|
0
|
0
|
0
|
|
Cohort 2B
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
87
|
63
|
63
|
|
Cohort 2B
Period 1-6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
87
|
63
|
63
|
|
Cohort 2B
Period 7
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
63
|
62
|
63
|
|
Cohort 2B
Period 8
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
62
|
61
|
61
|
|
Cohort 2B
Period 9
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
62
|
61
|
59
|
|
Cohort 2B
Period 10
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
61
|
61
|
59
|
|
Cohort 2B
Period 11
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
60
|
61
|
59
|
|
Cohort 2B
Period 12
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
60
|
61
|
58
|
|
Cohort 2B
Period 13
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
59
|
60
|
58
|
|
Cohort 2B
Period 14
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
58
|
60
|
57
|
|
Cohort 2B
Period 15
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
58
|
60
|
57
|
|
Cohort 2B
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
58
|
60
|
56
|
|
Cohort 2B
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
29
|
3
|
7
|
Reasons for withdrawal
| Measure |
Part A: LY3502970 QD Oral Administration (Cohort 1A, Sequence 1)
Participants received LY3502970 orally once daily (QD) across inpatient Treatment Periods 1-12 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows:
* Period 1: 1 mg (Capsule)
* Period 2: Dose Level 2 (Tablet)
* Period 3: Dose Level 1 (Tablet)
* Period 4: Dose Level 3 (Tablet)
* Period 5: 3 mg (Capsule)
* Period 6: Dose Level 5 (Tablet)
* Period 7: Dose Level 4 (Tablet)
* Period 8: Dose Level 6 (Tablet)
* Period 9: 6 mg (Capsule)
* Period 10: Dose Level 8 (Tablet)
* Period 11: Dose Level 7 (Tablet)
* Period 12: Dose Level 9 (Tablet)
|
Part A: LY3502970 Oral Administration (Cohort 1A, Sequence 2)
Participants received LY3502970 orally QD across inpatient Treatment Periods 1-12 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows:
* Period 1: Dose Level 2 (Tablet)
* Period 2: 1 mg (Capsule)
* Period 3: Dose Level 3 (Tablet)
* Period 4: Dose Level 1 (Tablet)
* Period 5: Dose Level 5 (Tablet)
* Period 6: 3 mg (Capsule)
* Period 7: Dose Level 6 (Tablet)
* Period 8: Dose Level 4 (Tablet)
* Period 9: Dose Level 8 (Tablet)
* Period 10: 6 mg (Capsule)
* Period 11: Dose Level 9 (Tablet)
* Period 12: Dose Level 7 (Tablet)
|
Part A: LY3502970 Oral Administration (Cohort 1A, Sequence 3)
Participants received LY3502970 orally QD across inpatient Treatment Periods 1-12 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows:
* Period 1: Dose Level 1 (Tablet)
* Period 2: Dose Level 3 (Tablet)
* Period 3: 1 mg (Capsule)
* Period 4: Dose Level 2 (Tablet)
* Period 5: Dose Level 4 (Tablet)
* Period 6: Dose Level 6 (Tablet)
* Period 7: 3 mg (Capsule)
* Period 8: Dose Level 5 (Tablet)
* Period 9: Dose Level 7 (Tablet)
* Period 10: Dose Level 9 (Tablet)
* Period 11: 6 mg (Capsule)
* Period 12: Dose Level 8 (Tablet)
|
Part A: LY3502970 Oral Administration (Cohort 1A, Sequence 4)
Participants received LY3502970 orally QD across inpatient Treatment Periods 1-12 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows:
* Period 1: Dose Level 3 (Tablet)
* Period 2: Dose Level 1 (Tablet)
* Period 3: Dose Level 2 (Tablet)
* Period 4: 1 mg (Capsule)
* Period 5: Dose Level 6 (Tablet)
* Period 6: Dose Level 4 (Tablet)
* Period 7: Dose Level 5 (Tablet)
* Period 8: 3 mg (Capsule)
* Period 9: Dose Level 9 (Tablet)
* Period 10: Dose Level 7 (Tablet)
* Period 11: Dose Level 8 (Tablet)
* Period 12: 6 mg (Capsule)
|
Part A: LY3502970 Oral Administration (Cohort 2A, Sequence 1)
Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg and 6 mg; Capsule), followed by inpatient Treatment Periods 7-18 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows:
* Period 7: 12 mg (Capsule)
* Period 8: Dose Level 11 (Tablet)
* Period 9: Dose Level 10 (Tablet)
* Period 10: Dose Level 12 (Tablet)
* Period 11: 24 mg (Capsule)
* Period 12: Dose Level 14 (Tablet)
* Period 13: Dose Level 13 (Tablet)
* Period 14: Dose Level 15 (Tablet)
* Period 15: 36 mg (Capsule)
* Period 16: Dose Level 17 (Tablet)
* Period 17: Dose Level 16 (Tablet)
* Period 18: Dose Level 18 (Tablet)
|
Part A: LY3502970 Oral Administration (Cohort 2A, Sequence 2)
Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg, and 6 mg; Capsule), followed by inpatient Treatment Periods 7-18 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows:
* Period 7: Dose Level 11 (Tablet)
* Period 8: 12 mg (Capsule)
* Period 9: Dose Level 12 (Tablet)
* Period 10: Dose Level 10 (Tablet)
* Period 11: Dose Level 14 (Tablet)
* Period 12: 24 mg (Capsule)
* Period 13: Dose Level 15 (Tablet)
* Period 14: Dose Level 13 (Tablet)
* Period 15: Dose Level 17 (Tablet)
* Period 16: 36 mg (Capsule)
* Period 17: Dose Level 18 (Tablet)
* Period 18: Dose Level 16 (Tablet)
|
Part A: LY3502970 Oral Administration (Cohort 2A, Sequence 3)
Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg and 6 mg; Capsule), followed by inpatient Treatment Periods 7-18 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows:
* Period 7: Dose Level 10 (Tablet)
* Period 8: Dose Level 12 (Tablet)
* Period 9: 12 mg (Capsule)
* Period 10: Dose Level 11 (Tablet)
* Period 11: Dose Level 13 (Tablet)
* Period 12: Dose Level 15 (Tablet)
* Period 13: 24 mg (Capsule)
* Period 14: Dose Level 14 (Tablet)
* Period 15: Dose Level 16 (Tablet)
* Period 16: Dose Level 18 (Tablet)
* Period 17: 36 mg (Capsule)
* Period 18: Dose Level 17 (Tablet)
|
Part A: LY3502970 Oral Administration (Cohort 2A, Sequence 4)
Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg, and 6 mg; Capsule), followed by inpatient Treatment Periods 7-18 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows:
* Period 7: Dose Level 12 (Tablet)
* Period 8: Dose Level 10 (Tablet)
* Period 9: Dose Level 11 (Tablet)
* Period 10: 12 mg (Capsule)
* Period 11: Dose Level 15 (Tablet)
* Period 12: Dose Level 13 (Tablet)
* Period 13: Dose Level 14 (Tablet)
* Period 14: 24 mg (Capsule)
* Period 15: Dose Level 18 (Tablet)
* Period 16: Dose Level 15 (Tablet)
* Period 17: Dose Level 17 (Tablet)
* Period 18: 36 mg (Capsule)
|
Part B: LY3502970 Oral Administration (Cohort 1B, Sequence 1)
Participants received LY3502970 orally QD across inpatient Treatment Periods 1-9 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows:
* Period 1: 1 mg (Capsule- First Treatment)
* Period 2: 1 mg (Capsule- Second Treatment)
* Period 3: 0.8 mg (Tablet)
* Period 4: 3 mg (Capsule- First Treatment)
* Period 5: 3 mg (Capsule- Second Treatment)
* Period 6: 2.5 mg (Tablet)
* Period 7: 6 mg (Capsule- First Treatment)
* Period 8: 6 mg (Capsule- Second Treatment)
* Period 9: 5.5 mg (Tablet)
|
Part B: LY3502970 Oral Administration (Cohort 1B, Sequence 2)
Participants received LY3502970 orally QD across inpatient Treatment Periods 1-9 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows:
* Period 1: 1 mg (Capsule- First Treatment)
* Period 2: 0.8 mg (Tablet)
* Period 3: 1 mg (Capsule- Second Treatment)
* Period 4: 3 mg (Capsule- First Treatment)
* Period 5: 2.5 mg (Tablet)
* Period 6: 3 mg (Capsule- Second Treatment)
* Period 7: 6 mg (Capsule- First Treatment)
* Period 8: 5.5 mg (Tablet)
* Period 9: 6 mg (Capsule- Second Treatment)
|
Part B: LY3502970 Oral Administration (Cohort 1B, Sequence 3)
Participants received LY3502970 orally QD across inpatient Treatment Periods 1-9 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows:
* Period 1: 0.8 mg (Tablet)
* Period 2: 1 mg (Capsule- First Treatment)
* Period 3: 1 mg (Capsule- Second Treatment)
* Period 4: 2.5 mg (Tablet)
* Period 5: 3 mg (Capsule- First Treatment)
* Period 6: 3 mg (Capsule- Second Treatment)
* Period 7: 5.5 mg (Tablet)
* Period 8: 6 mg (Capsule- First Treatment)
* Period 9: 6 mg (Capsule- Second Treatment)
|
Part B: LY3502970 Oral Administration (Cohort 2B, Sequence 1)
Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg, and 6 mg \[Capsule\]), followed by inpatient Treatment Periods 7-15 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows:
* Period 7: 12 mg (Capsule- First Treatment)
* Period 8: 12 mg (Capsule- Second Treatment)
* Period 9: 9 mg (Tablet)
* Period 10: 24 mg (Capsule- First Treatment)
* Period 11: 24 mg (Capsule- Second Treatment)
* Period 12: 14.5 mg (Tablet)
* Period 13: 36 mg (Capsule- First Treatment)
* Period 14: 36 mg (Capsule- Second Treatment)
* Period 15: 17.2 mg (Tablet)
|
Part B: LY3502970 Oral Administration (Cohort 2B, Sequence 2)
Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg, and 6 mg \[Capsule\]), followed by inpatient Treatment Periods 7-15 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows:
* Period 7: 12 mg (Capsule- First Treatment)
* Period 8: 9 mg (Tablet)
* Period 9: 12 mg (Capsule- Second Treatment)
* Period 10: 24 mg (Capsule- First Treatment)
* Period 11: 14.5 mg (Tablet)
* Period 12: 24 mg (Capsule- Second Treatment)
* Period 13: 36 mg (Capsule- First Treatment)
* Period 14: 17.2 mg (Tablet)
* Period 15: 36 mg (Capsule- Second Treatment)
|
Part B: LY3502970 Oral Administration (Cohort 2B, Sequence 3)
Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg, and 6 mg \[Capsule\]), followed by inpatient Treatment Periods 7-15 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows:
* Period 7: 9 mg (Tablet)
* Period 8: 12 mg (Capsule- First Treatment)
* Period 9: 12 mg (Capsule- Second Treatment)
* Period 10: 14.5 mg (Tablet)
* Period 11: 24 mg (Capsule- First Treatment)
* Period 12: 24 mg (Capsule- Second Treatment)
* Period 13: 17.2 mg (Tablet)
* Period 14: 36 mg (Capsule- First Treatment)
* Period 15: 36 mg (Capsule- Second Treatment)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cohort 1A
Adverse Event
|
0
|
0
|
3
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 1A
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 1A
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 2A
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 2A
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 2A
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 1B
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
0
|
0
|
0
|
|
Cohort 1B
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
2
|
0
|
0
|
0
|
|
Cohort 1B
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
5
|
2
|
0
|
0
|
0
|
|
Cohort 2B
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
1
|
4
|
|
Cohort 2B
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
1
|
1
|
|
Cohort 2B
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
1
|
2
|
|
Cohort 2B
Non-Compliance With Study Drug
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Cohort 2B
Screen Failure
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Cohort 2B
Protocol Deviation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
Baseline Characteristics
A Study to Compare Tablets and Capsules of Orforglipron (LY3502970) in Healthy Participants Who Are Obese or Overweight
Baseline characteristics by cohort
| Measure |
Part A: LY3502970 Oral Administration - Cohort 1A
n=52 Participants
* Participants in Cohort 1A received LY3502970 administered orally once daily as capsules or tablets at dose levels corresponding to capsule doses of 1 mg, 3 mg, and 6 mg.
* Participants received each of the three capsule doses and tablets at dose strengths corresponding to the capsule dose levels.
* Study treatment was administered across 12 dosing periods, with each dosing period lasting 7 days.
|
Part A: LY3502970 Oral Administration - Cohort 2A
n=52 Participants
* Participants in Cohort 2A received LY3502970 administered orally once daily as capsules or tablets at dose levels corresponding to capsule doses of 12 mg, 24 mg, and 36 mg.
* Treatment included an initial 6-period at-home dosing phase with capsule dosing only, followed by 12 inpatient dosing periods.
* During the inpatient period, participants received each of the three capsule doses and tablets at dose strengths corresponding to the capsule dose levels.
* Overall, study treatment was administered across a total of 18 dosing periods (6 at-home and 12 inpatient), each lasting 7 days.
|
Part B: LY3502970 Oral Administration - Cohort 1B
n=216 Participants
* Participants in Cohort 1B received LY3502970 administered orally once daily as capsules or tablets at dose levels corresponding to capsule doses of 1 mg, 3 mg, and 6 mg.
* Participants received each of the two capsule doses and tablets at dose strengths corresponding to the capsule dose levels.
* Study treatment was administered across 9 dosing periods, with each dosing period lasting 7 days.
|
Part B: LY3502970 Oral Administration - Cohort 2B
n=213 Participants
* Participants in Cohort 2B received LY3502970 administered orally once daily as capsules or tablets at dose levels corresponding to capsule doses of 12 mg, 24 mg, and 36 mg.
* Treatment included an initial 6-period at-home dosing phase with capsule dosing only, followed by 12 inpatient dosing periods.
* During the inpatient period, participants received each of the two capsule doses and tablets at dose strengths corresponding to the capsule dose levels.
* Overall, study treatment was administered across a total of 15 dosing periods (6 at-home and 9 inpatient), each lasting 7 days.
|
Total
n=533 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
45.9 Years
STANDARD_DEVIATION 10.74 • n=20 Participants
|
42.8 Years
STANDARD_DEVIATION 10.28 • n=20 Participants
|
44.7 Years
STANDARD_DEVIATION 11.12 • n=40 Participants
|
42.1 Years
STANDARD_DEVIATION 10.50 • n=5 Participants
|
45.6 Years
STANDARD_DEVIATION 10.83 • n=9 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=20 Participants
|
17 Participants
n=20 Participants
|
93 Participants
n=40 Participants
|
82 Participants
n=5 Participants
|
214 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=20 Participants
|
35 Participants
n=20 Participants
|
123 Participants
n=40 Participants
|
131 Participants
n=5 Participants
|
319 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
53 Participants
n=40 Participants
|
66 Participants
n=5 Participants
|
142 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=20 Participants
|
40 Participants
n=20 Participants
|
163 Participants
n=40 Participants
|
146 Participants
n=5 Participants
|
390 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=20 Participants
|
21 Participants
n=20 Participants
|
99 Participants
n=40 Participants
|
81 Participants
n=5 Participants
|
223 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=20 Participants
|
30 Participants
n=20 Participants
|
106 Participants
n=40 Participants
|
121 Participants
n=5 Participants
|
284 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
52 Participants
n=20 Participants
|
52 Participants
n=20 Participants
|
216 Participants
n=40 Participants
|
213 Participants
n=5 Participants
|
533 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose on Day 7 for each dosing treatment period (1 period=7 days)Population: The PK population included all enrolled participants who received at least one dose of study drug and had evaluable pharmacokinetic data for this specific outcome measure. As pre-specified in the statistical analysis plan, only participants with valid data from all three treatment periods (two capsule treatment and one tablet treatment) corresponding to the relevant dose level were included in the analysis.
PK: Area under the concentration versus time curve from time 0 to the end of the once daily dosing interval at steady state AUC\[0-tau\] on Day 7.
Outcome measures
| Measure |
Cohort 1B: 1 mg LY3502970 Capsule QD (First Treatment)
n=213 Participants
Participants who received 1 mg LY3502970 administered orally once daily as a capsule during the first treatment of Cohort 1B were included in this arm.
|
Cohort 1B: 1 mg LY3502970 Capsule QD (Second Treatment)
n=210 Participants
Participants who received 1 mg LY3502970 administered orally once daily as a capsule during the second treatment of Cohort 1B were included in this arm.
|
Cohort 1B: 0.8 mg LY3502970 Tablet QD
n=211 Participants
Participants in Cohort 1B received LY3502970 administered orally once daily as a tablet at a dose of 0.8 mg (corresponding to the 1 mg capsule dose) were included in this arm.
|
Cohort 1B: 3 mg LY3502970 Capsule QD (First Treatment)
n=205 Participants
Participants who received 3 mg LY3502970 administered orally once daily as a capsule during the first treatment of Cohort 1B were included in this arm.
|
Cohort 1B: 3 mg LY3502970 Capsule QD (Second Treatment)
n=204 Participants
Participants who received 3 mg LY3502970 administered orally once daily as a capsule during the second treatment of Cohort 1B were included in this arm.
|
Cohort 1B: 2.5 mg LY3502970 Tablet QD
n=207 Participants
Participants in Cohort 1B received LY3502970 administered orally once daily as a tablet at a dose of 2.5 mg (corresponding to the 3 mg capsule dose) were included in this arm.
|
Cohort 1B: 6 mg LY3502970 Capsule QD (First Treatment)
n=196 Participants
Participants who received 6 mg LY3502970 administered orally once daily as a capsule during the first treatment of Cohort 1B were included in this arm.
|
Cohort 1B: 6 mg LY3502970 Capsule QD (Second Treatment)
n=196 Participants
Participants who received 6 mg LY3502970 administered orally once daily as a capsule during the second treatment of Cohort 1B were included in this arm.
|
Cohort 1B: 5.5 mg LY3502970 Tablet QD
n=199 Participants
Participants in Cohort 1B received LY3502970 administered orally once daily as a tablet at a dose of 5.5 mg (corresponding to the 6 mg capsule dose) were included in this arm.
|
Cohort 2B: 12 mg LY3502970 Capsule QD (First Treatment)
n=176 Participants
Participants who received 12 mg LY3502970 administered orally once daily as a capsule during the first treatment of Cohort 2B were included in this arm.
|
Cohort 2B: 12 mg LY3502970 Capsule QD (Second Treatment)
n=179 Participants
Participants who received 12 mg LY3502970 administered orally once daily as a capsule during the second treatment of Cohort 2B were included in this arm.
|
Cohort 2B: 9 mg LY3502970 Tablet QD
n=182 Participants
Participants in Cohort 2B received LY3502970 administered orally once daily as a tablet at a dose of 9 mg (corresponding to the 12 mg capsule dose) were included in this arm.
|
Cohort 2B: 24 mg LY3502970 Capsule QD (First Treatment)
n=175 Participants
Participants who received 24 mg LY3502970 administered orally once daily as a capsule during the first treatment of Cohort 2B were included in this arm.
|
Cohort 2B: 24 mg LY3502970 Capsule QD (Second Treatment)
n=177 Participants
Participants who received 24 mg LY3502970 administered orally once daily as a capsule during the second treatment of Cohort 2B were included in this arm.
|
Cohort 2B: 14.5 mg LY3502970 Tablet QD
n=179 Participants
Participants in Cohort 2B received LY3502970 administered orally once daily as a tablet at a dose of 14.5 mg (corresponding to the 24 mg capsule dose) were included in this arm.
|
Cohort 2B: 36 mg LY3502970 Capsule QD (First Treatment)
n=173 Participants
Participants who received 36 mg LY3502970 administered orally once daily as a capsule during the first treatment of Cohort 2B were included in this arm.
|
Cohort 2B: 36 mg LY3502970 Capsule QD (Second Treatment)
n=170 Participants
Participants who received 36 mg LY3502970 administered orally once daily as a capsule during the second treatment of Cohort 2B were included in this arm.
|
Cohort 2B: 17.2 mg LY3502970 Tablet QD
n=173 Participants
Participants in Cohort 2B received LY3502970 administered orally once daily as a tablet at a dose of 17.2 mg (corresponding to the 36 mg capsule dose) were included in this arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Pharmacokinetics (PK): Steady-state Area Under the Concentration Time Curve From Time Zero to the End of the Dosing Interval, Tau (AUC[0-tau]) of LY3502970 on Day 7
|
80.2 Nanogram* hours/milliliter (ng*h/ml)
Geometric Coefficient of Variation 37.8
|
82.1 Nanogram* hours/milliliter (ng*h/ml)
Geometric Coefficient of Variation 39.7
|
78.9 Nanogram* hours/milliliter (ng*h/ml)
Geometric Coefficient of Variation 36.6
|
240 Nanogram* hours/milliliter (ng*h/ml)
Geometric Coefficient of Variation 38.8
|
252 Nanogram* hours/milliliter (ng*h/ml)
Geometric Coefficient of Variation 39.1
|
247 Nanogram* hours/milliliter (ng*h/ml)
Geometric Coefficient of Variation 37.3
|
517 Nanogram* hours/milliliter (ng*h/ml)
Geometric Coefficient of Variation 47.4
|
541 Nanogram* hours/milliliter (ng*h/ml)
Geometric Coefficient of Variation 60.4
|
524 Nanogram* hours/milliliter (ng*h/ml)
Geometric Coefficient of Variation 45.4
|
829 Nanogram* hours/milliliter (ng*h/ml)
Geometric Coefficient of Variation 46.4
|
841 Nanogram* hours/milliliter (ng*h/ml)
Geometric Coefficient of Variation 46.3
|
790 Nanogram* hours/milliliter (ng*h/ml)
Geometric Coefficient of Variation 40.3
|
1210 Nanogram* hours/milliliter (ng*h/ml)
Geometric Coefficient of Variation 50.0
|
1260 Nanogram* hours/milliliter (ng*h/ml)
Geometric Coefficient of Variation 57.5
|
1200 Nanogram* hours/milliliter (ng*h/ml)
Geometric Coefficient of Variation 64.2
|
1500 Nanogram* hours/milliliter (ng*h/ml)
Geometric Coefficient of Variation 71.5
|
1500 Nanogram* hours/milliliter (ng*h/ml)
Geometric Coefficient of Variation 71.9
|
1520 Nanogram* hours/milliliter (ng*h/ml)
Geometric Coefficient of Variation 60.4
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose on Day 7 for each dosing treatment period (1 period=7 days)Population: The PK population included all enrolled participants who received at least one dose of study drug and had evaluable pharmacokinetic data for this specific outcome measure. As pre-specified in the statistical analysis plan, only participants with valid data from all three treatment periods (two capsule treatment and one tablet treatment) corresponding to the relevant dose level were included in the analysis.
PK: Maximum concentration of LY3502970 during a once daily dosing interval at steady state on Day 7.
Outcome measures
| Measure |
Cohort 1B: 1 mg LY3502970 Capsule QD (First Treatment)
n=213 Participants
Participants who received 1 mg LY3502970 administered orally once daily as a capsule during the first treatment of Cohort 1B were included in this arm.
|
Cohort 1B: 1 mg LY3502970 Capsule QD (Second Treatment)
n=210 Participants
Participants who received 1 mg LY3502970 administered orally once daily as a capsule during the second treatment of Cohort 1B were included in this arm.
|
Cohort 1B: 0.8 mg LY3502970 Tablet QD
n=211 Participants
Participants in Cohort 1B received LY3502970 administered orally once daily as a tablet at a dose of 0.8 mg (corresponding to the 1 mg capsule dose) were included in this arm.
|
Cohort 1B: 3 mg LY3502970 Capsule QD (First Treatment)
n=205 Participants
Participants who received 3 mg LY3502970 administered orally once daily as a capsule during the first treatment of Cohort 1B were included in this arm.
|
Cohort 1B: 3 mg LY3502970 Capsule QD (Second Treatment)
n=204 Participants
Participants who received 3 mg LY3502970 administered orally once daily as a capsule during the second treatment of Cohort 1B were included in this arm.
|
Cohort 1B: 2.5 mg LY3502970 Tablet QD
n=207 Participants
Participants in Cohort 1B received LY3502970 administered orally once daily as a tablet at a dose of 2.5 mg (corresponding to the 3 mg capsule dose) were included in this arm.
|
Cohort 1B: 6 mg LY3502970 Capsule QD (First Treatment)
n=196 Participants
Participants who received 6 mg LY3502970 administered orally once daily as a capsule during the first treatment of Cohort 1B were included in this arm.
|
Cohort 1B: 6 mg LY3502970 Capsule QD (Second Treatment)
n=196 Participants
Participants who received 6 mg LY3502970 administered orally once daily as a capsule during the second treatment of Cohort 1B were included in this arm.
|
Cohort 1B: 5.5 mg LY3502970 Tablet QD
n=200 Participants
Participants in Cohort 1B received LY3502970 administered orally once daily as a tablet at a dose of 5.5 mg (corresponding to the 6 mg capsule dose) were included in this arm.
|
Cohort 2B: 12 mg LY3502970 Capsule QD (First Treatment)
n=177 Participants
Participants who received 12 mg LY3502970 administered orally once daily as a capsule during the first treatment of Cohort 2B were included in this arm.
|
Cohort 2B: 12 mg LY3502970 Capsule QD (Second Treatment)
n=179 Participants
Participants who received 12 mg LY3502970 administered orally once daily as a capsule during the second treatment of Cohort 2B were included in this arm.
|
Cohort 2B: 9 mg LY3502970 Tablet QD
n=182 Participants
Participants in Cohort 2B received LY3502970 administered orally once daily as a tablet at a dose of 9 mg (corresponding to the 12 mg capsule dose) were included in this arm.
|
Cohort 2B: 24 mg LY3502970 Capsule QD (First Treatment)
n=175 Participants
Participants who received 24 mg LY3502970 administered orally once daily as a capsule during the first treatment of Cohort 2B were included in this arm.
|
Cohort 2B: 24 mg LY3502970 Capsule QD (Second Treatment)
n=177 Participants
Participants who received 24 mg LY3502970 administered orally once daily as a capsule during the second treatment of Cohort 2B were included in this arm.
|
Cohort 2B: 14.5 mg LY3502970 Tablet QD
n=179 Participants
Participants in Cohort 2B received LY3502970 administered orally once daily as a tablet at a dose of 14.5 mg (corresponding to the 24 mg capsule dose) were included in this arm.
|
Cohort 2B: 36 mg LY3502970 Capsule QD (First Treatment)
n=173 Participants
Participants who received 36 mg LY3502970 administered orally once daily as a capsule during the first treatment of Cohort 2B were included in this arm.
|
Cohort 2B: 36 mg LY3502970 Capsule QD (Second Treatment)
n=170 Participants
Participants who received 36 mg LY3502970 administered orally once daily as a capsule during the second treatment of Cohort 2B were included in this arm.
|
Cohort 2B: 17.2 mg LY3502970 Tablet QD
n=173 Participants
Participants in Cohort 2B received LY3502970 administered orally once daily as a tablet at a dose of 17.2 mg (corresponding to the 36 mg capsule dose) were included in this arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: PK: Steady-state Maximum Observed Concentration (Cmax) of LY3502970 on Day 7
|
5.39 Nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 37.9
|
5.60 Nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 39.5
|
5.38 Nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 35.9
|
16.2 Nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 41.2
|
16.8 Nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 38.8
|
16.8 Nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 37.4
|
35.1 Nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 50.0
|
36.8 Nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 63.6
|
34.9 Nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 63.9
|
55.0 Nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 55.0
|
55.6 Nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 51.3
|
53.5 Nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 41.7
|
80.0 Nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 52.1
|
82.6 Nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 60.6
|
82.2 Nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 67.7
|
96.9 Nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 74.4
|
96.2 Nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 75.8
|
105 Nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 65.2
|
Adverse Events
Cohort 1A: 1 mg LY3502970 Capsule QD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 1A: LY3502970 Tablet QD (Dose Level 1)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 1A: LY3502970 Tablet QD (Dose Level 2)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 1A: LY3502970 Tablet QD (Dose Level 3)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort 1A: 3 mg LY3502970 Capsule QD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 1A: LY3502970 Tablet QD (Dose Level 4)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort 1A: LY3502970 Tablet QD (Dose Level 5)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 1A: LY3502970 Tablet QD (Dose Level 6)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Cohort 1A: 6 mg LY3502970 Capsule QD
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 1A: LY3502970 Tablet QD (Dose Level 7)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 1A: LY3502970 Tablet QD (Dose Level 8)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 1A: LY3502970 Tablet QD (Dose Level 9)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 2A: 1/3/6 mg LY3502970 Capsule QD (Home Dosing)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Cohort 2A: 12 mg LY3502970 Capsule QD
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 2A: LY3502970 Tablet QD (Dose Level 10)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Cohort 2A:LY3502970 Tablet QD (Dose Level 11)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Cohort 2A: LY3502970 Tablet QD (Dose Level 12)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 2A: 24 mg LY3502970 Capsule QD
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Cohort 2A: LY3502970 Tablet QD (Dose Level 13)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 2A: LY3502970 Tablet QD (Dose Level 14)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Cohort 2A: LY3502970 Tablet QD (Dose Level 15)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 2A: 36 mg LY3502970 Capsule QD
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort 2A: LY3502970 Tablet QD (Dose Level 16)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort 2A:LY3502970 Tablet QD (Dose Level 17)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort 2A: LY3502970 Tablet QD (Dose Level 18)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort 1B: 1 mg LY3502970 Capsule QD
Serious events: 0 serious events
Other events: 92 other events
Deaths: 0 deaths
Cohort 1B: 0.8 mg LY3502970 Tablet QD
Serious events: 0 serious events
Other events: 49 other events
Deaths: 0 deaths
Cohort 1B: 3 mg LY3502970 Capsule QD
Serious events: 0 serious events
Other events: 96 other events
Deaths: 0 deaths
Cohort 1B: 2.5 mg LY3502970 Tablet QD
Serious events: 0 serious events
Other events: 57 other events
Deaths: 0 deaths
Cohort 1B: 6 mg LY3502970 Capsule QD
Serious events: 1 serious events
Other events: 80 other events
Deaths: 0 deaths
Cohort 1B:5.5 mg LY3502970 Tablet QD
Serious events: 1 serious events
Other events: 51 other events
Deaths: 0 deaths
Cohort 2B:1/3/6 mg LY3502970 Capsule QD (Home Dosing)
Serious events: 0 serious events
Other events: 111 other events
Deaths: 0 deaths
Cohort 2B:12 mg LY3502970 Capsule QD
Serious events: 0 serious events
Other events: 97 other events
Deaths: 0 deaths
Cohort 2B:9 mg LY3502970 Tablet QD
Serious events: 0 serious events
Other events: 61 other events
Deaths: 0 deaths
Cohort 2B:24 mg LY3502970 Capsule QD
Serious events: 0 serious events
Other events: 85 other events
Deaths: 0 deaths
Cohort 2B:14.5 mg LY3502970 Tablet QD
Serious events: 0 serious events
Other events: 56 other events
Deaths: 0 deaths
Cohort 2B: 36 mg LY3502970 Capsule QD
Serious events: 1 serious events
Other events: 66 other events
Deaths: 0 deaths
Cohort 2B: 17.2 mg LY3502970 Tablet QD
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1A: 1 mg LY3502970 Capsule QD
n=52 participants at risk
Participants who received 1 mg LY3502970 administered orally once daily as a capsule in Cohort 1A were included in this arm.
|
Cohort 1A: LY3502970 Tablet QD (Dose Level 1)
n=52 participants at risk
Participants who received LY3502970 (dose level 1) administered orally once daily as a tablet in Cohort 1A were included in this arm.
|
Cohort 1A: LY3502970 Tablet QD (Dose Level 2)
n=52 participants at risk
Participants who received LY3502970 (dose level 2) administered orally once daily as a tablet in Cohort 1A were included in this arm.
|
Cohort 1A: LY3502970 Tablet QD (Dose Level 3)
n=52 participants at risk
Participants who received LY3502970 (dose level 3) administered orally once daily as a tablet in Cohort 1A were included in this arm.
|
Cohort 1A: 3 mg LY3502970 Capsule QD
n=47 participants at risk
Participants who received 3 mg LY3502970 administered orally once daily as a capsule in Cohort 1A were included in this arm.
|
Cohort 1A: LY3502970 Tablet QD (Dose Level 4)
n=51 participants at risk
Participants who received LY3502970 (dose level 4) administered orally once daily as a tablet in Cohort 1A were included in this arm.
|
Cohort 1A: LY3502970 Tablet QD (Dose Level 5)
n=48 participants at risk
Participants who received LY3502970 (dose level 5) administered orally once daily as a tablet in Cohort 1A were included in this arm.
|
Cohort 1A: LY3502970 Tablet QD (Dose Level 6)
n=51 participants at risk
Participants who received LY3502970 (dose level 6) administered orally once daily as a tablet in Cohort 1A were included in this arm.
|
Cohort 1A: 6 mg LY3502970 Capsule QD
n=46 participants at risk
Participants who received 6 mg LY3502970 administered orally once daily as a capsule in Cohort 1A were included in this arm.
|
Cohort 1A: LY3502970 Tablet QD (Dose Level 7)
n=46 participants at risk
Participants who received LY3502970 (dose level 7) administered orally once daily as a tablet in Cohort 1A were included in this arm.
|
Cohort 1A: LY3502970 Tablet QD (Dose Level 8)
n=47 participants at risk
Participants who received LY3502970 (dose level 8) administered orally once daily as a tablet in Cohort 1A were included in this arm.
|
Cohort 1A: LY3502970 Tablet QD (Dose Level 9)
n=46 participants at risk
Participants who received LY3502970 (dose level 9) administered orally once daily as a tablet in Cohort 1A were included in this arm.
|
Cohort 2A: 1/3/6 mg LY3502970 Capsule QD (Home Dosing)
n=52 participants at risk
Participants who received 1/3/6 mg LY3502970 administered orally once daily as a capsule in home dosing in Cohort 2A were included in this arm.
|
Cohort 2A: 12 mg LY3502970 Capsule QD
n=50 participants at risk
Participants who received 12 mg LY3502970 administered orally once daily as a capsule in Cohort 2A were included in this arm.
|
Cohort 2A: LY3502970 Tablet QD (Dose Level 10)
n=50 participants at risk
Participants who received LY3502970 (dose level 10) administered orally once daily as a tablet in Cohort 2A were included in this arm.
|
Cohort 2A:LY3502970 Tablet QD (Dose Level 11)
n=50 participants at risk
Participants who received LY3502970 (dose level 11) administered orally once daily as a tablet in Cohort 2A were included in this arm.
|
Cohort 2A: LY3502970 Tablet QD (Dose Level 12)
n=50 participants at risk
Participants who received LY3502970 (dose level 12) administered orally once daily as a tablet in Cohort 2A were included in this arm.
|
Cohort 2A: 24 mg LY3502970 Capsule QD
n=50 participants at risk
Participants who received 24 mg LY3502970 administered orally once daily as a capsule in Cohort 2A were included in this arm.
|
Cohort 2A: LY3502970 Tablet QD (Dose Level 13)
n=49 participants at risk
Participants who received LY3502970 (dose level 13) administered orally once daily as a tablet in Cohort 2A were included in this arm.
|
Cohort 2A: LY3502970 Tablet QD (Dose Level 14)
n=49 participants at risk
Participants who received LY3502970 (dose level 14) administered orally once daily as a tablet in Cohort 2A were included in this arm.
|
Cohort 2A: LY3502970 Tablet QD (Dose Level 15)
n=50 participants at risk
Participants who received LY3502970 (dose level 15) administered orally once daily as a tablet in Cohort 2A were included in this arm.
|
Cohort 2A: 36 mg LY3502970 Capsule QD
n=45 participants at risk
Participants who received 36 mg LY3502970 administered orally once daily as a capsule in Cohort 2A were included in this arm.
|
Cohort 2A: LY3502970 Tablet QD (Dose Level 16)
n=45 participants at risk
Participants who received LY3502970 (dose level 16) administered orally once daily as a tablet in Cohort 2A were included in this arm.
|
Cohort 2A:LY3502970 Tablet QD (Dose Level 17)
n=45 participants at risk
Participants who received LY3502970 (dose level 17) administered orally once daily as a tablet in Cohort 2A were included in this arm.
|
Cohort 2A: LY3502970 Tablet QD (Dose Level 18)
n=45 participants at risk
Participants who received LY3502970 (dose level 18) administered orally once daily as a tablet in Cohort 2A were included in this arm.
|
Cohort 1B: 1 mg LY3502970 Capsule QD
n=215 participants at risk
Participants who received 1 mg LY3502970 administered orally once daily as a capsule in Cohort 1B were included in this arm.
|
Cohort 1B: 0.8 mg LY3502970 Tablet QD
n=213 participants at risk
Participants who received 0.8 mg LY3502970 administered orally once daily as a tablet in Cohort 1B were included in this arm.
|
Cohort 1B: 3 mg LY3502970 Capsule QD
n=210 participants at risk
Participants who received 3 mg LY3502970 administered orally once daily as a capsule in Cohort 1B were included in this arm.
|
Cohort 1B: 2.5 mg LY3502970 Tablet QD
n=210 participants at risk
Participants who received 2.5 mg LY3502970 administered orally once daily as a tablet in Cohort 1B were included in this arm.
|
Cohort 1B: 6 mg LY3502970 Capsule QD
n=203 participants at risk
Participants who received 6 mg LY3502970 administered orally once daily as a capsule in Cohort 1B were included in this arm.
|
Cohort 1B:5.5 mg LY3502970 Tablet QD
n=203 participants at risk
Participants who received 5.5 mg LY3502970 administered orally once daily as a tablet in Cohort 1B were included in this arm.
|
Cohort 2B:1/3/6 mg LY3502970 Capsule QD (Home Dosing)
n=213 participants at risk
Participants who received 1/3/6 mg LY3502970 administered orally once daily as a capsule in home dosing in Cohort 2B were included in this arm.
|
Cohort 2B:12 mg LY3502970 Capsule QD
n=186 participants at risk
Participants who received 12 mg LY3502970 administered orally once daily as a capsule in Cohort 2B were included in this arm.
|
Cohort 2B:9 mg LY3502970 Tablet QD
n=186 participants at risk
Participants who received 9 mg LY3502970 administered orally once daily as a tablet in Cohort 2B were included in this arm.
|
Cohort 2B:24 mg LY3502970 Capsule QD
n=181 participants at risk
Participants who received 24 mg LY3502970 administered orally once daily as a capsule in Cohort 2B were included in this arm.
|
Cohort 2B:14.5 mg LY3502970 Tablet QD
n=180 participants at risk
Participants who received LY3502970 14.5 mg administered orally once daily as a tablet in Cohort 2B were included in this arm.
|
Cohort 2B: 36 mg LY3502970 Capsule QD
n=176 participants at risk
Participants who received 36 mg LY3502970 administered orally once daily as a capsule in Cohort 2B were included in this arm.
|
Cohort 2B: 17.2 mg LY3502970 Tablet QD
n=176 participants at risk
Participants who received 17.2 mg LY3502970 administered orally once daily as a tablet in Cohort 2B were included in this arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/47 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/51 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/48 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/51 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/46 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/46 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/47 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/46 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/49 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/49 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/215 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/213 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/210 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/210 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/203 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/203 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/213 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/186 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/186 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/181 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/180 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.57%
1/176 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/176 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/47 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/51 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/48 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/51 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/46 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/46 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/47 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/46 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/49 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/49 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/215 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/213 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/210 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/210 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.49%
1/203 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/203 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/213 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/186 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/186 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/181 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/180 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/176 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/176 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/47 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/51 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/48 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/51 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/46 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/46 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/47 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/46 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.0%
1/49 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/49 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/215 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/213 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/210 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/210 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/203 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/203 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/213 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/186 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/186 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/181 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/180 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/176 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/176 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/47 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/51 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/48 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/51 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/46 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/46 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/47 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/46 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/49 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/49 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/215 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/213 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/210 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/210 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/203 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.49%
1/203 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/213 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/186 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/186 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/181 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/180 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/176 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/176 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
Other adverse events
| Measure |
Cohort 1A: 1 mg LY3502970 Capsule QD
n=52 participants at risk
Participants who received 1 mg LY3502970 administered orally once daily as a capsule in Cohort 1A were included in this arm.
|
Cohort 1A: LY3502970 Tablet QD (Dose Level 1)
n=52 participants at risk
Participants who received LY3502970 (dose level 1) administered orally once daily as a tablet in Cohort 1A were included in this arm.
|
Cohort 1A: LY3502970 Tablet QD (Dose Level 2)
n=52 participants at risk
Participants who received LY3502970 (dose level 2) administered orally once daily as a tablet in Cohort 1A were included in this arm.
|
Cohort 1A: LY3502970 Tablet QD (Dose Level 3)
n=52 participants at risk
Participants who received LY3502970 (dose level 3) administered orally once daily as a tablet in Cohort 1A were included in this arm.
|
Cohort 1A: 3 mg LY3502970 Capsule QD
n=47 participants at risk
Participants who received 3 mg LY3502970 administered orally once daily as a capsule in Cohort 1A were included in this arm.
|
Cohort 1A: LY3502970 Tablet QD (Dose Level 4)
n=51 participants at risk
Participants who received LY3502970 (dose level 4) administered orally once daily as a tablet in Cohort 1A were included in this arm.
|
Cohort 1A: LY3502970 Tablet QD (Dose Level 5)
n=48 participants at risk
Participants who received LY3502970 (dose level 5) administered orally once daily as a tablet in Cohort 1A were included in this arm.
|
Cohort 1A: LY3502970 Tablet QD (Dose Level 6)
n=51 participants at risk
Participants who received LY3502970 (dose level 6) administered orally once daily as a tablet in Cohort 1A were included in this arm.
|
Cohort 1A: 6 mg LY3502970 Capsule QD
n=46 participants at risk
Participants who received 6 mg LY3502970 administered orally once daily as a capsule in Cohort 1A were included in this arm.
|
Cohort 1A: LY3502970 Tablet QD (Dose Level 7)
n=46 participants at risk
Participants who received LY3502970 (dose level 7) administered orally once daily as a tablet in Cohort 1A were included in this arm.
|
Cohort 1A: LY3502970 Tablet QD (Dose Level 8)
n=47 participants at risk
Participants who received LY3502970 (dose level 8) administered orally once daily as a tablet in Cohort 1A were included in this arm.
|
Cohort 1A: LY3502970 Tablet QD (Dose Level 9)
n=46 participants at risk
Participants who received LY3502970 (dose level 9) administered orally once daily as a tablet in Cohort 1A were included in this arm.
|
Cohort 2A: 1/3/6 mg LY3502970 Capsule QD (Home Dosing)
n=52 participants at risk
Participants who received 1/3/6 mg LY3502970 administered orally once daily as a capsule in home dosing in Cohort 2A were included in this arm.
|
Cohort 2A: 12 mg LY3502970 Capsule QD
n=50 participants at risk
Participants who received 12 mg LY3502970 administered orally once daily as a capsule in Cohort 2A were included in this arm.
|
Cohort 2A: LY3502970 Tablet QD (Dose Level 10)
n=50 participants at risk
Participants who received LY3502970 (dose level 10) administered orally once daily as a tablet in Cohort 2A were included in this arm.
|
Cohort 2A:LY3502970 Tablet QD (Dose Level 11)
n=50 participants at risk
Participants who received LY3502970 (dose level 11) administered orally once daily as a tablet in Cohort 2A were included in this arm.
|
Cohort 2A: LY3502970 Tablet QD (Dose Level 12)
n=50 participants at risk
Participants who received LY3502970 (dose level 12) administered orally once daily as a tablet in Cohort 2A were included in this arm.
|
Cohort 2A: 24 mg LY3502970 Capsule QD
n=50 participants at risk
Participants who received 24 mg LY3502970 administered orally once daily as a capsule in Cohort 2A were included in this arm.
|
Cohort 2A: LY3502970 Tablet QD (Dose Level 13)
n=49 participants at risk
Participants who received LY3502970 (dose level 13) administered orally once daily as a tablet in Cohort 2A were included in this arm.
|
Cohort 2A: LY3502970 Tablet QD (Dose Level 14)
n=49 participants at risk
Participants who received LY3502970 (dose level 14) administered orally once daily as a tablet in Cohort 2A were included in this arm.
|
Cohort 2A: LY3502970 Tablet QD (Dose Level 15)
n=50 participants at risk
Participants who received LY3502970 (dose level 15) administered orally once daily as a tablet in Cohort 2A were included in this arm.
|
Cohort 2A: 36 mg LY3502970 Capsule QD
n=45 participants at risk
Participants who received 36 mg LY3502970 administered orally once daily as a capsule in Cohort 2A were included in this arm.
|
Cohort 2A: LY3502970 Tablet QD (Dose Level 16)
n=45 participants at risk
Participants who received LY3502970 (dose level 16) administered orally once daily as a tablet in Cohort 2A were included in this arm.
|
Cohort 2A:LY3502970 Tablet QD (Dose Level 17)
n=45 participants at risk
Participants who received LY3502970 (dose level 17) administered orally once daily as a tablet in Cohort 2A were included in this arm.
|
Cohort 2A: LY3502970 Tablet QD (Dose Level 18)
n=45 participants at risk
Participants who received LY3502970 (dose level 18) administered orally once daily as a tablet in Cohort 2A were included in this arm.
|
Cohort 1B: 1 mg LY3502970 Capsule QD
n=215 participants at risk
Participants who received 1 mg LY3502970 administered orally once daily as a capsule in Cohort 1B were included in this arm.
|
Cohort 1B: 0.8 mg LY3502970 Tablet QD
n=213 participants at risk
Participants who received 0.8 mg LY3502970 administered orally once daily as a tablet in Cohort 1B were included in this arm.
|
Cohort 1B: 3 mg LY3502970 Capsule QD
n=210 participants at risk
Participants who received 3 mg LY3502970 administered orally once daily as a capsule in Cohort 1B were included in this arm.
|
Cohort 1B: 2.5 mg LY3502970 Tablet QD
n=210 participants at risk
Participants who received 2.5 mg LY3502970 administered orally once daily as a tablet in Cohort 1B were included in this arm.
|
Cohort 1B: 6 mg LY3502970 Capsule QD
n=203 participants at risk
Participants who received 6 mg LY3502970 administered orally once daily as a capsule in Cohort 1B were included in this arm.
|
Cohort 1B:5.5 mg LY3502970 Tablet QD
n=203 participants at risk
Participants who received 5.5 mg LY3502970 administered orally once daily as a tablet in Cohort 1B were included in this arm.
|
Cohort 2B:1/3/6 mg LY3502970 Capsule QD (Home Dosing)
n=213 participants at risk
Participants who received 1/3/6 mg LY3502970 administered orally once daily as a capsule in home dosing in Cohort 2B were included in this arm.
|
Cohort 2B:12 mg LY3502970 Capsule QD
n=186 participants at risk
Participants who received 12 mg LY3502970 administered orally once daily as a capsule in Cohort 2B were included in this arm.
|
Cohort 2B:9 mg LY3502970 Tablet QD
n=186 participants at risk
Participants who received 9 mg LY3502970 administered orally once daily as a tablet in Cohort 2B were included in this arm.
|
Cohort 2B:24 mg LY3502970 Capsule QD
n=181 participants at risk
Participants who received 24 mg LY3502970 administered orally once daily as a capsule in Cohort 2B were included in this arm.
|
Cohort 2B:14.5 mg LY3502970 Tablet QD
n=180 participants at risk
Participants who received LY3502970 14.5 mg administered orally once daily as a tablet in Cohort 2B were included in this arm.
|
Cohort 2B: 36 mg LY3502970 Capsule QD
n=176 participants at risk
Participants who received 36 mg LY3502970 administered orally once daily as a capsule in Cohort 2B were included in this arm.
|
Cohort 2B: 17.2 mg LY3502970 Tablet QD
n=176 participants at risk
Participants who received 17.2 mg LY3502970 administered orally once daily as a tablet in Cohort 2B were included in this arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.9%
1/52 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/47 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/51 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/48 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/51 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.2%
1/46 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/46 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/47 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
6.5%
3/46 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
3.8%
2/52 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/49 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/49 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.47%
1/215 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.94%
2/213 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.48%
1/210 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.95%
2/210 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
3.0%
6/203 • Number of events 6 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.49%
1/203 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
6.1%
13/213 • Number of events 17 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
3.2%
6/186 • Number of events 7 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.6%
3/186 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
5.0%
9/181 • Number of events 9 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
3.3%
6/180 • Number of events 6 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.1%
2/176 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/176 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
3.8%
2/52 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/47 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
3.9%
2/51 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.1%
1/48 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
3.9%
2/51 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/46 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/46 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/47 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
6.5%
3/46 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.0%
2/50 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.0%
1/50 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.0%
2/50 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.1%
2/49 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.1%
2/49 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.2%
1/45 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.2%
1/45 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.93%
2/215 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.94%
2/213 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.4%
3/210 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.95%
2/210 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
3.4%
7/203 • Number of events 7 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.99%
2/203 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.9%
4/213 • Number of events 4 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.7%
5/186 • Number of events 5 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.1%
2/186 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
3.3%
6/181 • Number of events 7 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.56%
1/180 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.8%
5/176 • Number of events 5 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.57%
1/176 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
|
Gastrointestinal disorders
Constipation
|
7.7%
4/52 • Number of events 4 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
9.6%
5/52 • Number of events 6 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.9%
1/52 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
13.5%
7/52 • Number of events 7 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/47 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
5.9%
3/51 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.1%
1/48 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
3.9%
2/51 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.2%
1/46 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/46 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/47 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/46 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
9.6%
5/52 • Number of events 6 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
6.0%
3/50 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
8.0%
4/50 • Number of events 4 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.0%
2/50 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.0%
1/50 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.0%
2/50 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
8.2%
4/49 • Number of events 4 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/49 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.0%
2/50 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.4%
2/45 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.4%
2/45 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.2%
1/45 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
6.7%
3/45 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
27.0%
58/215 • Number of events 62 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
8.9%
19/213 • Number of events 19 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
9.5%
20/210 • Number of events 21 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
6.2%
13/210 • Number of events 13 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
7.4%
15/203 • Number of events 16 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.9%
10/203 • Number of events 10 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
18.3%
39/213 • Number of events 44 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
21.0%
39/186 • Number of events 39 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
9.1%
17/186 • Number of events 17 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
10.5%
19/181 • Number of events 21 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
3.3%
6/180 • Number of events 6 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.5%
8/176 • Number of events 8 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.8%
5/176 • Number of events 5 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.9%
1/52 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
3.8%
2/52 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.1%
1/47 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
5.9%
3/51 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.2%
2/48 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
5.9%
3/51 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/46 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/46 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/47 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.3%
2/46 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.9%
1/52 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.0%
1/50 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
6.0%
3/50 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.0%
2/50 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.0%
2/50 • Number of events 5 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.1%
2/49 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.1%
2/49 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.0%
2/50 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.2%
1/45 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.2%
1/45 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.4%
2/45 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
6.7%
3/45 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.4%
3/215 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.94%
2/213 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
3.3%
7/210 • Number of events 7 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.4%
3/210 • Number of events 4 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.5%
3/203 • Number of events 4 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.5%
3/203 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
8.9%
19/213 • Number of events 21 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
10.2%
19/186 • Number of events 22 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.7%
5/186 • Number of events 5 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
12.7%
23/181 • Number of events 27 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
6.7%
12/180 • Number of events 13 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
6.2%
11/176 • Number of events 11 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.3%
4/176 • Number of events 4 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.9%
1/52 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.9%
1/52 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.1%
1/47 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
5.9%
3/51 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
6.2%
3/48 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.0%
1/51 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.3%
2/46 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.3%
2/46 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
6.4%
3/47 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.2%
1/46 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.9%
1/52 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
6.0%
3/50 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
6.0%
3/50 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.0%
1/50 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.1%
2/49 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.0%
1/49 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
3.7%
8/215 • Number of events 8 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.7%
10/213 • Number of events 10 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
5.7%
12/210 • Number of events 12 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
5.7%
12/210 • Number of events 13 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
7.9%
16/203 • Number of events 19 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.4%
9/203 • Number of events 9 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
7.5%
16/213 • Number of events 19 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
7.5%
14/186 • Number of events 18 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.8%
9/186 • Number of events 9 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
7.2%
13/181 • Number of events 13 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
3.9%
7/180 • Number of events 7 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.5%
8/176 • Number of events 8 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.8%
5/176 • Number of events 6 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
|
Gastrointestinal disorders
Eructation
|
1.9%
1/52 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.9%
1/52 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/47 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.0%
1/51 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/48 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
3.9%
2/51 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/46 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/46 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/47 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.2%
1/46 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
5.8%
3/52 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.0%
1/50 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.0%
1/50 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.0%
1/49 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.0%
1/49 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.47%
1/215 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.47%
1/213 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.48%
1/210 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.95%
2/210 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.49%
1/203 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.49%
1/203 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
3.8%
8/213 • Number of events 8 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
3.2%
6/186 • Number of events 7 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.2%
4/186 • Number of events 4 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.55%
1/181 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.56%
1/180 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/176 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.1%
2/176 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
|
Gastrointestinal disorders
Nausea
|
1.9%
1/52 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.9%
1/52 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.9%
1/52 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.3%
2/47 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
7.8%
4/51 • Number of events 5 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
8.3%
4/48 • Number of events 4 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
3.9%
2/51 • Number of events 5 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/46 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
6.5%
3/46 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.3%
2/47 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
10.9%
5/46 • Number of events 7 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
13.5%
7/52 • Number of events 9 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
6.0%
3/50 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
6.0%
3/50 • Number of events 4 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.0%
1/50 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
8.0%
4/50 • Number of events 4 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.0%
2/50 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.1%
2/49 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.1%
2/49 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
8.0%
4/50 • Number of events 4 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.2%
1/45 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
13.3%
6/45 • Number of events 6 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.4%
2/45 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
6.0%
13/215 • Number of events 14 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
3.3%
7/213 • Number of events 7 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
13.8%
29/210 • Number of events 29 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
6.2%
13/210 • Number of events 13 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
9.4%
19/203 • Number of events 19 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
8.4%
17/203 • Number of events 17 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
20.7%
44/213 • Number of events 54 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
17.2%
32/186 • Number of events 37 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
6.5%
12/186 • Number of events 13 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
17.1%
31/181 • Number of events 31 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
8.3%
15/180 • Number of events 15 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
5.1%
9/176 • Number of events 9 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
3.4%
6/176 • Number of events 6 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.9%
1/52 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.1%
1/47 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
7.8%
4/51 • Number of events 4 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.1%
1/48 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
3.9%
2/51 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.3%
2/46 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.2%
1/46 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.3%
2/47 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.3%
2/46 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
7.7%
4/52 • Number of events 5 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.0%
1/50 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.0%
2/50 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.0%
1/50 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
6.0%
3/50 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.1%
2/49 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.1%
2/49 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.0%
1/50 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.2%
1/45 • Number of events 4 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.4%
2/45 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.4%
2/45 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.2%
1/45 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.9%
4/215 • Number of events 4 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.9%
4/213 • Number of events 5 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
7.6%
16/210 • Number of events 33 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
3.3%
7/210 • Number of events 14 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
7.4%
15/203 • Number of events 28 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.9%
10/203 • Number of events 12 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
11.3%
24/213 • Number of events 32 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
11.8%
22/186 • Number of events 31 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
8.1%
15/186 • Number of events 16 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
9.4%
17/181 • Number of events 32 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
5.0%
9/180 • Number of events 10 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
10.8%
19/176 • Number of events 38 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
5.7%
10/176 • Number of events 13 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
|
General disorders
Fatigue
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.9%
1/52 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/47 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/51 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/48 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
3.9%
2/51 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/46 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/46 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/47 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/46 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
5.8%
3/52 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.0%
1/49 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.0%
1/49 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.4%
3/215 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.4%
3/213 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
3.8%
8/210 • Number of events 8 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.48%
1/210 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.99%
2/203 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/203 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
5.6%
12/213 • Number of events 13 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
3.8%
7/186 • Number of events 7 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.1%
2/186 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.55%
1/181 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.1%
2/180 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.1%
2/176 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/176 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
|
Investigations
Heart rate increased
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/47 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/51 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/48 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/51 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/46 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/46 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/47 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/46 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.0%
1/50 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.0%
1/50 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.0%
1/50 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/49 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.0%
1/49 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.0%
1/50 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
8.9%
4/45 • Number of events 5 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.2%
1/45 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/215 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/213 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.4%
3/210 • Number of events 4 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.48%
1/210 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.49%
1/203 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/203 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.3%
5/213 • Number of events 5 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.6%
3/186 • Number of events 5 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.1%
2/186 • Number of events 4 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.8%
5/181 • Number of events 5 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.1%
2/180 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.8%
5/176 • Number of events 7 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.3%
4/176 • Number of events 5 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.9%
1/52 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.1%
1/47 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/51 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/48 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/51 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/46 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/46 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/47 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/46 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.9%
1/52 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.0%
1/50 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/49 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/49 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.0%
1/50 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.2%
1/45 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
3.7%
8/215 • Number of events 8 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.9%
4/213 • Number of events 4 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
7.1%
15/210 • Number of events 15 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.4%
3/210 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.5%
3/203 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.49%
1/203 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
20.2%
43/213 • Number of events 47 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.54%
1/186 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.7%
5/186 • Number of events 5 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.2%
4/181 • Number of events 4 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.8%
5/180 • Number of events 5 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.57%
1/176 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.1%
2/176 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.9%
1/52 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/47 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
3.9%
2/51 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.1%
1/48 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.0%
1/51 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.2%
1/46 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/46 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/47 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/46 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.9%
1/52 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.0%
1/50 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/50 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.0%
1/50 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.0%
1/50 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.0%
2/50 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/49 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
12.2%
6/49 • Number of events 6 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.0%
2/50 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.4%
2/45 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/45 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.4%
2/45 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.2%
1/45 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.93%
2/215 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.94%
2/213 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.9%
4/210 • Number of events 4 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.4%
3/210 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.5%
5/203 • Number of events 5 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.49%
1/203 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
3.3%
7/213 • Number of events 8 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.8%
9/186 • Number of events 11 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.6%
3/186 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.4%
8/181 • Number of events 9 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
3.3%
6/180 • Number of events 6 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
3.4%
6/176 • Number of events 7 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.7%
3/176 • Number of events 5 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
|
Nervous system disorders
Headache
|
1.9%
1/52 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.9%
1/52 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
1.9%
1/52 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
0.00%
0/52 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.1%
1/47 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
3.9%
2/51 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
6.2%
3/48 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
3.9%
2/51 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
8.7%
4/46 • Number of events 5 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.3%
2/46 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.3%
2/47 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
6.5%
3/46 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
9.6%
5/52 • Number of events 5 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.0%
2/50 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
6.0%
3/50 • Number of events 4 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.0%
2/50 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
6.0%
3/50 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
10.0%
5/50 • Number of events 5 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.0%
1/49 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
6.1%
3/49 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.0%
2/50 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
6.7%
3/45 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
4.4%
2/45 • Number of events 2 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
6.7%
3/45 • Number of events 3 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
2.2%
1/45 • Number of events 1 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
15.8%
34/215 • Number of events 41 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
8.9%
19/213 • Number of events 20 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
17.6%
37/210 • Number of events 41 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
8.1%
17/210 • Number of events 18 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
12.3%
25/203 • Number of events 27 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
8.4%
17/203 • Number of events 22 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
10.8%
23/213 • Number of events 30 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
19.4%
36/186 • Number of events 46 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
9.7%
18/186 • Number of events 21 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
9.9%
18/181 • Number of events 19 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
8.3%
15/180 • Number of events 16 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
15.9%
28/176 • Number of events 32 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
3.4%
6/176 • Number of events 6 • Cohort 1A: Baseline Up to end of follow up (Up to 13 weeks); Cohort 2A: Baseline Up to end of follow up (Up to 19 weeks); Cohort 1B: Baseline Up to end of follow up (Up to 10 weeks); Cohort 2B: Baseline Up to end of follow up (Up to 16 weeks).
Safety population consisted of all participants who were exposed to at least 1 dose of study drug. As per the planned safety analysis, participants were analyzed as per the treatment they actually received. For Cohorts 2A and 2B, adverse events during the at-home dosing phase (Periods 1-6; sequential dose escalation of 1 mg, 3 mg, and 6 mg capsule) are pooled and reported as a single arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60